Newly Diagnosed Multiple Myeloma (NDMM)Phase 2NCT07891923
Less Doses of Daratumumab Are Adequate to Achieve Response in Newly Diagnosed Multiple Myeloma
A Phase 2 study testing Daratumumab (Intravenously), Bortezomib (BTZ) and Len (lenalidomide) in people with Newly Diagnosed Multiple Myeloma (NDMM), run by Tata Memorial Centre at 2 sites in India.
Trial summary
The goal of this clinical trial is to evaluate whether a modified (less frequent) dosing schedule of daratumumab, when added to standard VRd therapy, can be an effective induction regimen for treating newly diagnosed multiple myeloma (NDMM). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma (NDMM)
- What is being tested?
- Daratumumab (Intravenously), Bortezomib (BTZ) and Len (lenalidomide)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesIndia
- Study dates
- 28 Oct 2025to 5 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed multiple myeloma
- ECOG performance status 0-2
- Age ≥18 years of age
- Acceptable liver functions, as specified below: Total bilirubin <2 times upper limit of normal (ULN), Aspartate transaminase (AST; SGOT), alanine transaminase (ALT; SGPT) <3 ULN
- Acceptable hematological parameters: Hemoglobin >7g/dl, Absolute neutrophil count (ANC) ≥500/mm3, platelet count ≥50,000/mm3
- Creatinine clearance ≥30ml/minute (by Cockcroft-Gault formula)
- Treatment naive or received ≤ 1 cycle (≤28 days) of bortezomib based triplet therapy
Who cannot join
- Other plasma cell dyscrasias - Plasma cell leukemia (>=5% circulating plasma cells in peripheral blood), AL Amyloidosis, POEMS syndrome
- Patients with symptomatic central nervous system involvement (as per assessing clinician)
- Patients with symptomatic obstructive airway disease, as per assessing clinician
- New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction <40%
- Human immunodeficiency virus (HIV) positive or HBsAg positive
- Pregnant or breastfeeding female
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
Actrec Tmc
Navi Mumbai, Maharashtra, 410210
Sumeet Mirgh, MD, DM, +91-8130140245 ext. 02227405000, drsumeetmirgh@gmail.com
Anant Gokarn, MD, DM, anantgokarn@gmail.com
- Not yet recruiting
Dr.Sumeet Mirgh
Navi Mumbai, Maharashtra, 410210
Sumeet Mirgh, MD, DM, 91-8130140245, drsumeetmirgh@gmail.com
Anant Gokarn, MD, DM, 91-8097295540, anantgokarn@gmail.com
About this study
Official title: Less is Adequate - A Phase 2 Study of Less Frequent Dosing of Daratumumab in Newly Diagnosed Multiple Myeloma
The goal of this clinical trial is to evaluate whether a modified (less frequent) dosing schedule of daratumumab, when added to standard VRd therapy, can be an effective induction regimen for treating newly diagnosed multiple myeloma (NDMM).
The main questions it aims to answer are:
Read more
- Does the modified (less frequent) daratumumab dosing regimen increase the rate of MRD (minimal residual disease) negativity after 4 cycles of induction therapy (as compared to standard VRd therapy)?
- Is the modified less-frequent dosing schedule safe and does it achieve adequate drug levels
- What is the clinical response of patients to the treatment?
Treatment regimen Daratumumab (Dara), Bortezomib, Lenalidomide, and Dexamethasone will be given together for four cycles of induction therapy
Duration of each cycle will be 28 days
- Daratumumab will be given at standard dose of 16mg/kg - Day 1, 15, 29, 50, 71, and 92 (First three doses every 2 weeks, followed by the next three doses every 3 weeks). This will be given intravenously in saline
- Bortezomib: 1.3 mg/m2 - Given once weekly subcutaneously (similar to insulin)
- Lenalidomide: 15-25 mg orally for 21 days, followed by a 7-day gap.
- Dexamethasone: 40mg given once weekly
Response Assessment
- Response assessment - A bone marrow test will be done within two weeks of end of cycle 4 in order to assess the cancer burden via a special test called MRD (minimal residual disease) in the bone marrow.
- Blood tests will be performed to assess your response to treatment (serum protein electrophoresis, immunofixation electrophoresis and serum free light chain assay) after cycle 2 (between day 51-day 56) and cycle 4 (between 107-112). These blood tests are routinely done for all myeloma patients during their treatment to assess response.
Read the detailed description
- Research Design This will be a single arm, Phase 2, prospective, interventional study.
- Study Objectives
2a. Primary Objective
- The primary objective is to determine if the addition of a modified (less frequent) daratumumab schedule to VRd will increase MRD negativity at end of four cycles of induction (compared to historical data with VRd alone) 2b. Secondary Objective(s)
- To determine if modified daratumumab schedule when added to VRd will improve the clinical outcome as measured by
- Response rate means Overall response rate (ORR), and >=CR rate after 4 cycles post-induction
- Response rate means ORR, and >=CR rate at day 100 (±15 days) post ASCT
- 2-year PFS rate
- To assess the safety profile of modified daratumumab schedule (+VRd) protocol
- To assess MRD negativity at day 100(±15 days) post ASCT (in patients who undergo ASCT)
- Sustained MRD negativity (1-year apart) in patients who do not undergo ASCT
- To evaluate pharmacokinetics (PK) of daratumumab
- To evaluate stem-cell yield after mobilization
- To evaluate time to engraftment post-ASCT 2c. Exploratory objective
- To measure immune cell subsets
- Intervention
Patients will receive 4 cycles of Dara-VRd induction, with daratumumab administered as follows: Day 1, 15 , 29 , 50 , 71 , and 92 . Each 28-day cycle also includes weekly bortezomib (1.3 mg/m² SC/IV), lenalidomide (15-25 mg OD on days 1-21), and dexamethasone (40 mg weekly).
Following induction, transplant-eligible patients will proceed to autologous stem cell transplant (ASCT), while transplant-ineligible patients will continue VRd to a total of 9-12 cycles, followed by maintenance.
- Sample size - 52 patients
- Duration of study - 4 years
- Statistical Analytical Plan
- Analysis for MRD negativity, response, safety and PFS
Data will be tabulated in Microsoft-Excel sheet, and analyzed using SPSS v23.0. Data will be analyzed descriptively. MRD negativity rate and 95% CIs will be calculated using the Clopper-Pearson method. PFS will be analyzed using the Kaplan-Meier method. PFS will be defined as the time from the date of initiation of induction therapy to the date of disease progression or death due to any cause, whichever occurs first. Safety analyses will be performed in all patients who had received at least one dose of study treatment (safety population). Association between MRD and exploratory subgroups (standard vs high risk cytogenetics) will be assessed using Fisher's exact test. Summary statistics will be provided for clinical and demographic characteristics and for adverse events.
- Pharmacokinetic analysis
Pharmacokinetic model: The pharmacokinetic analysis will utilize a previously validated two-compartment model to characterize daratumumab behavior in the body, incorporating both linear clearance, which accounts for nonspecific IgG clearance, and Michaelis-Menten elimination, which captures saturable target-mediated clearance mechanisms. This model will account for interindividual variability (IIV) in clearance and volume of distribution. The concentration-time data collected according to the pharmacokinetic sampling plan will be fitted to this model. The population pharmacokinetic analysis will be performed using a nonlinear mixed-effect model approach with Pumas software (Version 2.5.1; MD, USA).
Covariates: The covariates with biological/physiological importance will be tested in a stepwise fashion. Covariate effects will be assessed for statistical significance using asymptotic 95% confidence intervals (CIs). Model-predicted PK exposure metrics will be generated for subgroup analyses based on relevant covariates.
Model evaluation: Goodness-of-fit plots will be evaluated with visual inspection of the following diagnostic scatter plots- population predicted concentrations (PRED) versus observed concentrations (DV), individual predicted concentrations (IPRED) versus DV and time after dosing versus weighted residuals (WRES). The nonparametric bootstrap resampling technique will be adopted to validate the reliability and stability of the final model. The stability and performance of the final model will be assessed using a visual predictive check (VPC).
Exposure-response evaluation: In terms of efficacy, responders will be defined as patients achieving MRD negativity. Safety evaluations will focus on grade ≥3 treatment-emergent AEs (TEAEs). Relationships between daratumumab exposure measures (AUC / maximum concentration (C max) and maximum trough concentration (C trough-max) and MRD negativity / AEs will be explored using exposure quartiles.
- Immune-cell subset analysis
Continuous data will be presented as mean/median/SD and categorical data as frequencies and proportions. The quantitative differences between the continuous variables such as immune cell subsets in MM patients against categorical parameters such as cytogenetics, and MRD status, will be evaluated using the Mann-Whitney-U test. The association of immune cell parameters with negative or positive MRD will be evaluated using the odds ratio (OR). A two-sided P value less than 0.05 will be considered statistically significant.
- Conditions
- Newly Diagnosed Multiple Myeloma (NDMM)
- Being tested
- Daratumumab (Intravenously), Bortezomib (BTZ), Len (lenalidomide), Dexamethasone
- Keywords
- newly diagnosed multiple myeloma, Less frequent daratumumab, Induction, Minimal residual disease (MRD), Pharmacokinetics, Prospective study, Interventional phase 2 study
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab (Intravenously)Drug
Daratumumab will be administered intravenously at 16 mg/kg according to the protocol-specified schedule (Days 1, 15, 29, 50, 71, and 92), during the four-cycle induction period.
Bortezomib (BTZ)Drug
Bortezomib will be administered at 1.3 mg/m² weekly, by the subcutaneous or intravenous route, as specified in the study protocol.
Len (lenalidomide)Drug
Lenalidomide will be administered orally at a dose of 15-25 mg once daily for 21 days of each 28-day cycle, as specified in the study protocol.
DexamethasoneDrug
Dexamethasone will be administered at a dose of 40 mg once weekly, orally or intravenously, as specified in the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Daratumumab with VRd (Bortezomib, Lenalidomide, and Dexamethasone) | Experimental | This arm includes patients with newly diagnosed multiple myeloma (NDMM) who meet all the inclusion and exclusion criteria. Eligible patients will receive four cycles of Dara-VRd induction therapy, with each cycle lasting 28 days. The regimen comprises daratumumab, bortezomib, lenalidomide, and dexamethasone, administered according to the specified dosing schedule. Receives: Drug: Daratumumab (Intravenously); Drug: Bortezomib (BTZ); Drug: Len (lenalidomide); Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-induction MRD negativity rate
Proportion of participants achieving measurable (minimal) residual disease (MRD) negativity at the end of four cycles of induction therapy with daratumumab, bortezomib, lenalidomide, and dexamethasone (Dara-VRd). MRD negativity will be assessed
Measured: At the end of Cycle 4 (each induction cycle is 28 days; MRD assessed within 2 weeks after completion of Cycle 4 [approximately Days 113-127]
Secondary outcomes (9)
Overall Response Rate (ORR) and ≥Complete Response (≥CR) Rate After Four Cycles of Induction
ORR (defined as the proportions of subjects who achieved PR or better) and ≥CR (as per the IMWG criteria) After 4 cycles post-induction
Measured: At the end of Cycle 4 (each induction cycle is 28 days; response assessed between Days 107 and 112).
Overall Response Rate (ORR) and ≥Complete Response (≥CR) Rate Day 100 (±15 days) post-transplant
ORR (defined as the proportions of subjects who achieved PR or better) and ≥CR (as per the IMWG criteria) at day100 (± 15 days) post-transplant
Measured: Day 100 (±15 days) following autologous hematopoietic stem cell transplant
Progression-Free Survival (PFS)
Progression-free survival (PFS), defined as the time from treatment initiation to documented disease progression or death from any cause, whichever occurs first.
Measured: From treatment initiation through 2 years of follow-up.
Incidence of Grade ≥3 Adverse Events
Incidence of treatment-emergent Grade 3 or higher adverse events, as assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0.
Measured: Up to 4 weeks after the last dose of study treatment.
Minimal residual disease (MRD)Negativity at Day 100 (±15 Days) Post-Autologous Stem Cell Transplantation (ASCT)
Proportion of participants who achieve measurable (minimal) residual disease (MRD) negativity at Day 100 (±15 days) following autologous stem cell Transplantation (ASCT), as assessed using the protocol-specified validated MRD assay
Measured: Day 100 (±15 days) following autologous stem cell transplantation (ASCT).
Sustained MRD negativity
Sustained MRD negativity (1-year apart) in patients who do not undergo ASCT
Measured: 1 year apart (non-ASCT pts)
pharmacokinetics (pK) of daratumumab
To evaluate pharmacokinetics (pK) of daratumumab The Pharmacokinetic study will be carried out during the 1st, 3rd and 6th dose of daratumumab.
Its time points are
1st dose (day 1): Pre-dose, end of infusion (EOI), EOI + 2 h, EOI + 5 h, and EOI + 24 h; any time during days 4 and 8; before the second pre-dose (day 15).
3rd dose (day 29): Pre-dose, end of infusion (EOI), EOI + 24 h; any time during days 36 and 43.
6th dose (day 92): Pre-dose, end of infusion (EOI), EOI + 24 h; any time during days 99 and 106.
Measured: From Day 1 (first daratumumab dose) through Day 106 (completion of PK sampling after the sixth daratumumab dose).
Stem-cell yield after mobilization
Proportion of participants who achieve a stem cell collection yield of ≥5 × 10⁶ CD34+ cells/kg body weight following mobilization with granulocyte colony-stimulating factor (G-CSF) and plerixafor.
Measured: During stem-cell mobilization and collection, up to 6 months after completion of four cycles of induction therapy and prior to ASCT.
Time to Engraftment Following Autologous Stem Cell Transplantation (ASCT)
Time from autologous stem cell transplantation (ASCT) to hematopoietic engraftment, defined as the first day of achieving an absolute neutrophil count (ANC) ≥0.5 × 10⁹/L and a platelet count ≥20 × 10⁹/L without platelet transfusion support, according to institutional criteria.
Measured: From the date of autologous stem cell transplantation (ASCT) until hematopoietic engraftment, assessed up to approx day 30 days after ASCT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start28 Oct 2025
- Primary completion5 May 2029 (estimated)
- Study completion5 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Newly Diagnosed Multiple Myeloma (NDMM)Studies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Dr Sumeet Mirgh, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891923
- Sponsor's protocol ID
- 901135
- Status last verified
- Oct 2026
- First submitted
- 11 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information in the study records will be kept confidential. The study participant's personal information will not be shared with any other parties unless explicit written consent is provided. No reference will be made in oral or written reports which could link study participant to the study. The clinical charts will be housed in the medical records department at ACTREC TMC. Data will be stored securely for a period of five years and will be made available only to persons conducting the study and to the regulatory authorities. Result of the study will not be communicated to the participant unless deemed necessary.
Publications
Tembhare P, Bagal B, Sriram H, et al. Concordance between peripheral blood MRD, bone marrow MRD and serum immunofixation in newly diagnosed multiple myeloma. ISLH 2024. https://onlinelibrary.wiley.com/doi/10.1111/ijlh.14396
Medina A, Puig N, Flores-Montero J, Jimenez C, Sarasquete ME, Garcia-Alvarez M, Prieto-Conde I, Chillon C, Alcoceba M, Gutierrez NC, Oriol A, Rosinol L, Blade J, Gironella M, Hernandez MT, Gonzalez-Calle V, Cedena MT, Paiva B, San-Miguel JF, Lahuerta JJ, Mateos MV, Martinez-Lopez J, Orfao A, Gonzalez M, Garcia-Sanz R. Comparison of next-generation sequencing (NGS) and next-generation flow (NGF) for minimal residual disease (MRD) assessment in multiple myeloma. Blood Cancer J. 2020 Oct 30;10(10):108. doi: 10.1038/s41408-020-00377-0.
PubMed 33127891Paiva B, Puig N, Cedena MT, Rosinol L, Cordon L, Vidriales MB, Burgos L, Flores-Montero J, Sanoja-Flores L, Lopez-Anglada L, Maldonado R, de la Cruz J, Gutierrez NC, Calasanz MJ, Martin-Ramos ML, Garcia-Sanz R, Martinez-Lopez J, Oriol A, Blanchard MJ, Rios R, Martin J, Martinez-Martinez R, Sureda A, Hernandez MT, de la Rubia J, Krsnik I, Moraleda JM, Palomera L, Bargay J, Van Dongen JJM, Orfao A, Mateos MV, Blade J, San-Miguel JF, Lahuerta JJ; GEM (Grupo Espanol de Mieloma)/PETHEMA (Programa Para el Estudio de la Terapeutica en Hemopatias Malignas) Cooperative Study Group. Measurable Residual Disease by Next-Generation Flow Cytometry in Multiple Myeloma. J Clin Oncol. 2020 Mar 10;38(8):784-792. doi: 10.1200/JCO.19.01231. Epub 2019 Nov 26.
PubMed 31770060US Department of Health and Human Services, National Institutes of Health, National Cancer Institute (2017) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 2017. https://ctep.cancer.gov/ protocolDevelopment/electronic_applications/docs/ CTCAE_v5_Quick_Reference_8.5x11.pdf. Accessed 01 May 2020
Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.
PubMed 27511158Tembhare PR, Sriram H, Chatterjee G, Khanka T, Gokarn A, Mirgh S, Rajendra A, Chaturvedi A, Ghogale SG, Deshpande N, Girase K, Dalvi K, Rajpal S, Patkar N, Trivedi B, Joshi A, Murthy V, Shetty N, Nair S, More A, Kamtalwar S, Chavan P, Bhat V, Bhat P, Subramanian PG, Gupta S, Khattry N. Comprehensive immune cell profiling depicts an early immune response associated with severe coronavirus disease 2019 in cancer patients. Immunol Cell Biol. 2022 Jan;100(1):61-73. doi: 10.1111/imcb.12504. Epub 2021 Oct 27.
PubMed 34582592Mai EK, Hielscher T, Bertsch U, Salwender HJ, Zweegman S, Raab MS, Munder M, Pantani L, Mancuso K, Brossart P, Beksac M, Blau IW, Durig J, Besemer B, Fenk R, Reimer P, van der Holt B, Hanel M, von Metzler I, Graeven U, Muller-Tidow C, Boccadoro M, Scheid C, Dimopoulos MA, Hillengass J, Weisel KC, Cavo M, Sonneveld P, Goldschmidt H. Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients. Leukemia. 2024 Mar;38(3):640-647. doi: 10.1038/s41375-023-02105-6. Epub 2023 Dec 7.
PubMed 38062124Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, Spicka I, Hungria V, Munder M, Mateos MV, Mark TM, Qi M, Schecter J, Amin H, Qin X, Deraedt W, Ahmadi T, Spencer A, Sonneveld P; CASTOR Investigators. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Aug 25;375(8):754-66. doi: 10.1056/NEJMoa1606038.
PubMed 27557302Plesner T, Arkenau HT, Gimsing P, Krejcik J, Lemech C, Minnema MC, Lassen U, Laubach JP, Palumbo A, Lisby S, Basse L, Wang J, Sasser AK, Guckert ME, de Boer C, Khokhar NZ, Yeh H, Clemens PL, Ahmadi T, Lokhorst HM, Richardson PG. Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma. Blood. 2016 Oct 6;128(14):1821-1828. doi: 10.1182/blood-2016-07-726729. Epub 2016 Aug 16.
PubMed 27531679Clemens PL, Yan X, Lokhorst HM, Lonial S, Losic N, Khan I, Jansson R, Ahmadi T, Lantz K, Zhou H, Puchalski T, Xu XS. Pharmacokinetics of Daratumumab Following Intravenous Infusion in Relapsed or Refractory Multiple Myeloma After Prior Proteasome Inhibitor and Immunomodulatory Drug Treatment. Clin Pharmacokinet. 2017 Aug;56(8):915-924. doi: 10.1007/s40262-016-0477-1.
PubMed 27896689Xu XS, Yan X, Puchalski T, Lonial S, Lokhorst HM, Voorhees PM, Plesner T, Liu K, Khan I, Jansson R, Ahmadi T, Ruixo JP, Zhou H, Clemens PL. Clinical Implications of Complex Pharmacokinetics for Daratumumab Dose Regimen in Patients With Relapsed/Refractory Multiple Myeloma. Clin Pharmacol Ther. 2017 Jun;101(6):721-724. doi: 10.1002/cpt.577. Epub 2017 Feb 13.
PubMed 27859027Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331. doi: 10.1056/NEJMoa1607751.
PubMed 27705267Dimopoulos MA, Terpos E, Boccadoro M, Delimpasi S, Beksac M, Katodritou E, Moreau P, Baldini L, Symeonidis A, Bila J, Oriol A, Mateos MV, Einsele H, Orfanidis I, Ahmadi T, Ukropec J, Kampfenkel T, Schecter JM, Qiu Y, Amin H, Vermeulen J, Carson R, Sonneveld P; APOLLO Trial Investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jun;22(6):801-812. doi: 10.1016/S1470-2045(21)00128-5.
PubMed 34087126Chim CS, Kumar S, Wong VKC, Ngai C, Kwong YL. 3-weekly daratumumab-lenalidomide/pomalidomide-dexamethasone is highly effective in relapsed and refractory multiple myeloma. Hematology. 2021 Dec;26(1):652-655. doi: 10.1080/16078454.2021.1965737.
PubMed 34474661Lonial S, Weiss BM, Usmani SZ, Singhal S, Chari A, Bahlis NJ, Belch A, Krishnan A, Vescio RA, Mateos MV, Mazumder A, Orlowski RZ, Sutherland HJ, Blade J, Scott EC, Oriol A, Berdeja J, Gharibo M, Stevens DA, LeBlanc R, Sebag M, Callander N, Jakubowiak A, White D, de la Rubia J, Richardson PG, Lisby S, Feng H, Uhlar CM, Khan I, Ahmadi T, Voorhees PM. Daratumumab monotherapy in patients with treatment-refractory multiple myeloma (SIRIUS): an open-label, randomised, phase 2 trial. Lancet. 2016 Apr 9;387(10027):1551-1560. doi: 10.1016/S0140-6736(15)01120-4. Epub 2016 Jan 7.
PubMed 26778538
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Less is Adequate - A Phase 2 Study of Less Frequent Dosing of Daratumumab in Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07891923
- Acronym / sponsor ID
- 901135
- Conditions
- Newly Diagnosed Multiple Myeloma (NDMM)
- Keywords
- newly diagnosed multiple myeloma, Less frequent daratumumab, Induction, Minimal residual disease (MRD), Pharmacokinetics, Prospective study, Interventional phase 2 study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 5 May 2029 (estimated)
- Study completion
- 5 May 2029 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether a modified (less frequent) dosing schedule of daratumumab, when added to standard VRd therapy, can be an effective induction regimen for treating newly diagnosed multiple myeloma (NDMM).
The main questions it aims to answer are:
- Does the modified (less frequent) daratumumab dosing regimen increase the rate of MRD (minimal residual disease) negativity after 4 cycles of induction therapy (as compared to standard VRd therapy)?
- Is the modified less-frequent dosing schedule safe and does it achieve adequate drug levels
- What is the clinical response of patients to the treatment?
Treatment regimen Daratumumab (Dara), Bortezomib, Lenalidomide, and Dexamethasone will be given together for four cycles of induction therapy
Duration of each cycle will be 28 days
- Daratumumab will be given at standard dose of 16mg/kg - Day 1, 15, 29, 50, 71, and 92 (First three doses every 2 weeks, followed by the next three doses every 3 weeks). This will be given intravenously in saline
- Bortezomib: 1.3 mg/m2 - Given once weekly subcutaneously (similar to insulin)
- Lenalidomide: 15-25 mg orally for 21 days, followed by a 7-day gap.
- Dexamethasone: 40mg given once weekly
Response Assessment
- Response assessment - A bone marrow test will be done within two weeks of end of cycle 4 in order to assess the cancer burden via a special test called MRD (minimal residual disease) in the bone marrow.
- Blood tests will be performed to assess your response to treatment (serum protein electrophoresis, immunofixation electrophoresis and serum free light chain assay) after cycle 2 (between day 51-day 56) and cycle 4 (between 107-112). These blood tests are routinely done for all myeloma patients during their treatment to assess response.
Detailed description
- Research Design This will be a single arm, Phase 2, prospective, interventional study.
- Study Objectives
2a. Primary Objective
- The primary objective is to determine if the addition of a modified (less frequent) daratumumab schedule to VRd will increase MRD negativity at end of four cycles of induction (compared to historical data with VRd alone) 2b. Secondary Objective(s)
- To determine if modified daratumumab schedule when added to VRd will improve the clinical outcome as measured by
- Response rate means Overall response rate (ORR), and >=CR rate after 4 cycles post-induction
- Response rate means ORR, and >=CR rate at day 100 (±15 days) post ASCT
- 2-year PFS rate
- To assess the safety profile of modified daratumumab schedule (+VRd) protocol
- To assess MRD negativity at day 100(±15 days) post ASCT (in patients who undergo ASCT)
- Sustained MRD negativity (1-year apart) in patients who do not undergo ASCT
- To evaluate pharmacokinetics (PK) of daratumumab
- To evaluate stem-cell yield after mobilization
- To evaluate time to engraftment post-ASCT 2c. Exploratory objective
- To measure immune cell subsets
- Intervention
Patients will receive 4 cycles of Dara-VRd induction, with daratumumab administered as follows: Day 1, 15 , 29 , 50 , 71 , and 92 . Each 28-day cycle also includes weekly bortezomib (1.3 mg/m² SC/IV), lenalidomide (15-25 mg OD on days 1-21), and dexamethasone (40 mg weekly).
Following induction, transplant-eligible patients will proceed to autologous stem cell transplant (ASCT), while transplant-ineligible patients will continue VRd to a total of 9-12 cycles, followed by maintenance.
- Sample size - 52 patients
- Duration of study - 4 years
- Statistical Analytical Plan
- Analysis for MRD negativity, response, safety and PFS
Data will be tabulated in Microsoft-Excel sheet, and analyzed using SPSS v23.0. Data will be analyzed descriptively. MRD negativity rate and 95% CIs will be calculated using the Clopper-Pearson method. PFS will be analyzed using the Kaplan-Meier method. PFS will be defined as the time from the date of initiation of induction therapy to the date of disease progression or death due to any cause, whichever occurs first. Safety analyses will be performed in all patients who had received at least one dose of study treatment (safety population). Association between MRD and exploratory subgroups (standard vs high risk cytogenetics) will be assessed using Fisher's exact test. Summary statistics will be provided for clinical and demographic characteristics and for adverse events.
- Pharmacokinetic analysis
Pharmacokinetic model: The pharmacokinetic analysis will utilize a previously validated two-compartment model to characterize daratumumab behavior in the body, incorporating both linear clearance, which accounts for nonspecific IgG clearance, and Michaelis-Menten elimination, which captures saturable target-mediated clearance mechanisms. This model will account for interindividual variability (IIV) in clearance and volume of distribution. The concentration-time data collected according to the pharmacokinetic sampling plan will be fitted to this model. The population pharmacokinetic analysis will be performed using a nonlinear mixed-effect model approach with Pumas software (Version 2.5.1; MD, USA).
Covariates: The covariates with biological/physiological importance will be tested in a stepwise fashion. Covariate effects will be assessed for statistical significance using asymptotic 95% confidence intervals (CIs). Model-predicted PK exposure metrics will be generated for subgroup analyses based on relevant covariates.
Model evaluation: Goodness-of-fit plots will be evaluated with visual inspection of the following diagnostic scatter plots- population predicted concentrations (PRED) versus observed concentrations (DV), individual predicted concentrations (IPRED) versus DV and time after dosing versus weighted residuals (WRES). The nonparametric bootstrap resampling technique will be adopted to validate the reliability and stability of the final model. The stability and performance of the final model will be assessed using a visual predictive check (VPC).
Exposure-response evaluation: In terms of efficacy, responders will be defined as patients achieving MRD negativity. Safety evaluations will focus on grade ≥3 treatment-emergent AEs (TEAEs). Relationships between daratumumab exposure measures (AUC / maximum concentration (C max) and maximum trough concentration (C trough-max) and MRD negativity / AEs will be explored using exposure quartiles.
- Immune-cell subset analysis
Continuous data will be presented as mean/median/SD and categorical data as frequencies and proportions. The quantitative differences between the continuous variables such as immune cell subsets in MM patients against categorical parameters such as cytogenetics, and MRD status, will be evaluated using the Mann-Whitney-U test. The association of immune cell parameters with negative or positive MRD will be evaluated using the odds ratio (OR). A two-sided P value less than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daratumumab with VRd (Bortezomib, Lenalidomide, and Dexamethasone) | Experimental | Drug: Daratumumab (Intravenously), Drug: Bortezomib (BTZ), Drug: Len (lenalidomide), Drug: DexamethasoneThis arm includes patients with newly diagnosed multiple myeloma (NDMM) who meet all the inclusion and exclusion criteria. Eligible patients will receive four cycles of Dara-VRd induction therapy, with each cycle lasting 28 days. The regimen comprises daratumumab, bortezomib, lenalidomide, and dexamethasone, administered according to the specified dosing schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed multiple myeloma
- ECOG performance status 0-2
- Age ≥18 years of age
- Acceptable liver functions, as specified below: Total bilirubin <2 times upper limit of normal (ULN), Aspartate transaminase (AST; SGOT), alanine transaminase (ALT; SGPT) <3 ULN
- Acceptable hematological parameters: Hemoglobin >7g/dl, Absolute neutrophil count (ANC) ≥500/mm3, platelet count ≥50,000/mm3
Key exclusion criteria (6 listed)
- Other plasma cell dyscrasias - Plasma cell leukemia (>=5% circulating plasma cells in peripheral blood), AL Amyloidosis, POEMS syndrome
- Patients with symptomatic central nervous system involvement (as per assessing clinician)
- Patients with symptomatic obstructive airway disease, as per assessing clinician
- New York Heart Association (NYHA) Class III or IV cardiac disease, or left ventricular ejection fraction <40%
- Human immunodeficiency virus (HIV) positive or HBsAg positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daratumumab (Intravenously)Daratumumab will be administered intravenously at 16 mg/kg according to the protocol-specified schedule (Days 1, 15, 29, 50, 71, and 92), during the four-cycle induction period. | Drug | Daratumumab with VRd (Bortezomib, Lenalidomide, and Dexamethasone) |
| Bortezomib (BTZ)Bortezomib will be administered at 1.3 mg/m² weekly, by the subcutaneous or intravenous route, as specified in the study protocol. | Drug | Daratumumab with VRd (Bortezomib, Lenalidomide, and Dexamethasone) |
| Len (lenalidomide)Lenalidomide will be administered orally at a dose of 15-25 mg once daily for 21 days of each 28-day cycle, as specified in the study protocol. | Drug | Daratumumab with VRd (Bortezomib, Lenalidomide, and Dexamethasone) |
| DexamethasoneDexamethasone will be administered at a dose of 40 mg once weekly, orally or intravenously, as specified in the study protocol. | Drug | Daratumumab with VRd (Bortezomib, Lenalidomide, and Dexamethasone) |
Primary outcome
Post-induction MRD negativity rate
Time frame: At the end of Cycle 4 (each induction cycle is 28 days; MRD assessed within 2 weeks after completion of Cycle 4 [approximately Days 113-127]
Proportion of participants achieving measurable (minimal) residual disease (MRD) negativity at the end of four cycles of induction therapy with daratumumab, bortezomib, lenalidomide, and dexamethasone (Dara-VRd). MRD negativity will be assessed
9 secondary outcomes
Overall Response Rate (ORR) and ≥Complete Response (≥CR) Rate After Four Cycles of Induction
Time frame: At the end of Cycle 4 (each induction cycle is 28 days; response assessed between Days 107 and 112).
Overall Response Rate (ORR) and ≥Complete Response (≥CR) Rate Day 100 (±15 days) post-transplant
Time frame: Day 100 (±15 days) following autologous hematopoietic stem cell transplant
Progression-Free Survival (PFS)
Time frame: From treatment initiation through 2 years of follow-up.
Incidence of Grade ≥3 Adverse Events
Time frame: Up to 4 weeks after the last dose of study treatment.
Minimal residual disease (MRD)Negativity at Day 100 (±15 Days) Post-Autologous Stem Cell Transplantation (ASCT)
Time frame: Day 100 (±15 days) following autologous stem cell transplantation (ASCT).
Sustained MRD negativity
Time frame: 1 year apart (non-ASCT pts)
pharmacokinetics (pK) of daratumumab
Time frame: From Day 1 (first daratumumab dose) through Day 106 (completion of PK sampling after the sixth daratumumab dose).
Stem-cell yield after mobilization
Time frame: During stem-cell mobilization and collection, up to 6 months after completion of four cycles of induction therapy and prior to ASCT.
Time to Engraftment Following Autologous Stem Cell Transplantation (ASCT)
Time frame: From the date of autologous stem cell transplantation (ASCT) until hematopoietic engraftment, assessed up to approx day 30 days after ASCT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publicationTembhare P, Bagal B, Sriram H, et al. Concordance between peripheral blood MRD, bone marrow MRD and serum immunofixation in newly diagnosed multiple myeloma. ISLH 2024. https://onlinelibrary.wiley.com/doi/10.1111/ijlh.14396
- Results publication: PubMed 33127891Medina A, Puig N, Flores-Montero J, Jimenez C, Sarasquete ME, Garcia-Alvarez M, Prieto-Conde I, Chillon C, Alcoceba M, Gutierrez NC, Oriol A, Rosinol L, Blade J, Gironella M, Hernandez MT, Gonzalez-Calle V, Cedena MT, Paiva B, San-Miguel JF, Lahuerta JJ, Mateos MV, Martinez-Lopez J, Orfao A, Gonzalez M, Garcia-Sanz R. Comparison of next-generation sequencing (NGS) and next-generation flow (NGF) for minimal residual disease (MRD) assessment in multiple myeloma. Blood Cancer J. 2020 Oct 30;10(10):108. doi: 10.1038/s41408-020-00377-0.
- Results publication: PubMed 31770060Paiva B, Puig N, Cedena MT, Rosinol L, Cordon L, Vidriales MB, Burgos L, Flores-Montero J, Sanoja-Flores L, Lopez-Anglada L, Maldonado R, de la Cruz J, Gutierrez NC, Calasanz MJ, Martin-Ramos ML, Garcia-Sanz R, Martinez-Lopez J, Oriol A, Blanchard MJ, Rios R, Martin J, Martinez-Martinez R, Sureda A, Hernandez MT, de la Rubia J, Krsnik I, Moraleda JM, Palomera L, Bargay J, Van Dongen JJM, Orfao A, Mateos MV, Blade J, San-Miguel JF, Lahuerta JJ; GEM (Grupo Espanol de Mieloma)/PETHEMA (Programa Para el Estudio de la Terapeutica en Hemopatias Malignas) Cooperative Study Group. Measurable Residual Disease by Next-Generation Flow Cytometry in Multiple Myeloma. J Clin Oncol. 2020 Mar 10;38(8):784-792. doi: 10.1200/JCO.19.01231. Epub 2019 Nov 26.
- Results publicationUS Department of Health and Human Services, National Institutes of Health, National Cancer Institute (2017) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 2017. https://ctep.cancer.gov/ protocolDevelopment/electronic_applications/docs/ CTCAE_v5_Quick_Reference_8.5x11.pdf. Accessed 01 May 2020
- Results publication: PubMed 27511158Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.
- Results publication: PubMed 34582592Tembhare PR, Sriram H, Chatterjee G, Khanka T, Gokarn A, Mirgh S, Rajendra A, Chaturvedi A, Ghogale SG, Deshpande N, Girase K, Dalvi K, Rajpal S, Patkar N, Trivedi B, Joshi A, Murthy V, Shetty N, Nair S, More A, Kamtalwar S, Chavan P, Bhat V, Bhat P, Subramanian PG, Gupta S, Khattry N. Comprehensive immune cell profiling depicts an early immune response associated with severe coronavirus disease 2019 in cancer patients. Immunol Cell Biol. 2022 Jan;100(1):61-73. doi: 10.1111/imcb.12504. Epub 2021 Oct 27.
- Results publication: PubMed 38062124Mai EK, Hielscher T, Bertsch U, Salwender HJ, Zweegman S, Raab MS, Munder M, Pantani L, Mancuso K, Brossart P, Beksac M, Blau IW, Durig J, Besemer B, Fenk R, Reimer P, van der Holt B, Hanel M, von Metzler I, Graeven U, Muller-Tidow C, Boccadoro M, Scheid C, Dimopoulos MA, Hillengass J, Weisel KC, Cavo M, Sonneveld P, Goldschmidt H. Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients. Leukemia. 2024 Mar;38(3):640-647. doi: 10.1038/s41375-023-02105-6. Epub 2023 Dec 7.
- Results publication: PubMed 27557302Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, Spicka I, Hungria V, Munder M, Mateos MV, Mark TM, Qi M, Schecter J, Amin H, Qin X, Deraedt W, Ahmadi T, Spencer A, Sonneveld P; CASTOR Investigators. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Aug 25;375(8):754-66. doi: 10.1056/NEJMoa1606038.
- Results publication: PubMed 27531679Plesner T, Arkenau HT, Gimsing P, Krejcik J, Lemech C, Minnema MC, Lassen U, Laubach JP, Palumbo A, Lisby S, Basse L, Wang J, Sasser AK, Guckert ME, de Boer C, Khokhar NZ, Yeh H, Clemens PL, Ahmadi T, Lokhorst HM, Richardson PG. Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma. Blood. 2016 Oct 6;128(14):1821-1828. doi: 10.1182/blood-2016-07-726729. Epub 2016 Aug 16.
- Results publication: PubMed 27896689Clemens PL, Yan X, Lokhorst HM, Lonial S, Losic N, Khan I, Jansson R, Ahmadi T, Lantz K, Zhou H, Puchalski T, Xu XS. Pharmacokinetics of Daratumumab Following Intravenous Infusion in Relapsed or Refractory Multiple Myeloma After Prior Proteasome Inhibitor and Immunomodulatory Drug Treatment. Clin Pharmacokinet. 2017 Aug;56(8):915-924. doi: 10.1007/s40262-016-0477-1.
- Results publication: PubMed 27859027Xu XS, Yan X, Puchalski T, Lonial S, Lokhorst HM, Voorhees PM, Plesner T, Liu K, Khan I, Jansson R, Ahmadi T, Ruixo JP, Zhou H, Clemens PL. Clinical Implications of Complex Pharmacokinetics for Daratumumab Dose Regimen in Patients With Relapsed/Refractory Multiple Myeloma. Clin Pharmacol Ther. 2017 Jun;101(6):721-724. doi: 10.1002/cpt.577. Epub 2017 Feb 13.
- Results publication: PubMed 27705267Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331. doi: 10.1056/NEJMoa1607751.
- Individual participant dataSharing planned: No. The information in the study records will be kept confidential. The study participant's personal information will not be shared with any other parties unless explicit written consent is provided. No reference will be made in oral or written reports which could link study participant to the study. The clinical charts will be housed in the medical records department at ACTREC TMC. Data will be stored securely for a period of five years and will be made available only to persons conducting the study and to the regulatory authorities. Result of the study will not be communicated to the participant unless deemed necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daratumumab (Intravenously), Bortezomib (BTZ) and Len (lenalidomide) in people with Newly Diagnosed Multiple Myeloma (NDMM), run by Tata Memorial Centre at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr.Sumeet Mirgh, MBBS MD DM Clinical Hematology (+91 8130140245, drsumeetmirgh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-induction MRD negativity rate (time frame: At the end of Cycle 4 (each induction cycle is 28 days; MRD assessed within 2 weeks after completion of Cycle 4 [approximately Days 113-127]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07891923, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.