Multiple MyelomaNCT06252792
Dara-PD in the Treatment of Patients With First Relapse of Multiple Myeloma
An observational study of Multiple Myeloma and First Relapse, run by FengYan Jin at 1 site in China.
Trial summary
At present, there is no prospective study on the treatment of first-relapsed multiple myeloma with daratumumab plus pomalidomide and dexamethasone (Dara-Pd). A prospective, multicenter, open, non-interventional, observational clinical study to evaluate the efficacy and safety of Dara-Pd in patients with first relapse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, First Relapse
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 15 Jun 2026
- Phase
- Observational
- 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
Study population: the first relapse of multiple myeloma
Who may be able to join
- Subjects will be enrolled in this study only if they met all of the following inclusion criteria.
- Age 18 years or older, regardless of gender.
- Diagnosis of symptomatic multiple myeloma based on the 2014 IMWG diagnostic criteria and the presence of measurable disease
- First relapse of multiple myeloma;
- Receiving first-line anti-multiple myeloma therapy;
- The first-line therapy must be based on proteasome inhibitors and immunomodulators (RVD);
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- Subject must have achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at one prior regimen;
- Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
- Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. Contraception must begin 4 weeks prior to dosing and continue until at least 3 months after receiving the last dose of the study drug. A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization.
Who cannot join
- Diagnosis of inactive multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance) or smoldering myeloma.
- Relapsed and refractory myeloma：Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course；
- Primary refractory myeloma：Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy；
- Subject has received daratumumab or pomalidomide previously；
- Subject has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions is malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).；
- Subjects with uncontrollable psychiatric disorders;
- Subject is known or suspected of not being able to comply with the study protocol.Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
FengYan Jin, +8617843082307, fengyanjin@jlu.edu.cn
About this study
Official title: Prospective, Multicenter, Open and Non-interference Observational Clinical Study of Daratumumab, Pomalidomide and Dexamethasone (Dara-PD) in the Treatment of Patients With First Relapse of Multiple Myeloma
At present, there is no prospective study on the treatment of first-relapsed multiple myeloma with daratumumab plus pomalidomide and dexamethasone (Dara-Pd). A prospective, multicenter, open, non-interventional, observational clinical study to evaluate the efficacy and safety of Dara-Pd in patients with first relapse multiple myeloma.
Read the detailed description
To evaluate the impact of daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma. Among them, the second progression free survival time (PFS2) is defined as the time from enrollment to disease progression or death.
- Conditions
- Multiple Myeloma, First Relapse
- Keywords
- Multiple Myeloma, First relapse, the second progression free survival time (PFS2)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| daratumumab, pomalidomide, and dexamethasone (Dara-PD) | the first relapse of patients who received daratumumab, pomalidomide, and dexamethasone (Dara-PD) treatment | |
| other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) | the first relapse of patients who received other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the second progression free survival time (PFS2)
daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma.
Measured: through study completion, up to 2 years
Secondary outcomes (7)
Objective Response Rate (ORR)
Evaluated according to the 2016 IMWG efficacy evaluation criteria, defined as the proportion of participants who achieved the best response as strict complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
Measured: through study completion, up to 2 years
Deep response rate (≥ VGPR)
Evaluated according to the 2016 IMWG efficacy evaluation criteria, defined as the proportion of subjects who achieved the best response as strict complete response (sCR), complete response (CR), and very good partial response (VGPR).
Measured: through study completion, up to 2 years
MRD negative
MRD negative is defined as bone marrow MRD negative confirmed by new generation flow cytometry (NGF) or new generation sequencing technology (NGS) (the minimum detection sensitivity is that one clonal plasma cell can be detected from 105 nucleated cells);
Measured: through study completion, up to 2 years
continuous MRD negative rate
Persistent MRD negative: new generation flow cytometry (NGF) or new generation sequencing technology (NGS) detects bone marrow MRD negative and imaging negative, with at least one year between two tests being negative
Measured: through study completion, up to 2 years
Overall survival (OS)
Overall survival (OS) evaluation: defined as the time from enrollment to death.
Measured: through study completion, up to 2 years
Evaluation of duration of remission (DOR)
Evaluation of duration of remission (DOR): defined as the time from the first response to treatment to disease progression or death
Measured: through study completion, up to 2 years
Treatment related adverse event(AE)
Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.
Measured: From enrollment through follow-up (up to 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start15 Jun 2023
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FengYan Jin
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Hebei University, Second Hospital of Shanxi Medical University, Shandong Cancer Hospital and Institute, First Affiliated Hospital of Jinan University, Sun Yat-Sen University Cancer Center
- Responsible party
- Sponsor-investigator, FengYan Jin, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252792
- Sponsor's protocol ID
- First relapse multiple myeloma
- Status last verified
- Jun 2025
- First submitted
- 21 Dec 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Majithia N, Rajkumar SV, Lacy MQ, Buadi FK, Dispenzieri A, Gertz MA, Hayman SR, Dingli D, Kapoor P, Hwa L, Lust JA, Russell SJ, Go RS, Kyle RA, Kumar SK. Early relapse following initial therapy for multiple myeloma predicts poor outcomes in the era of novel agents. Leukemia. 2016 Nov;30(11):2208-2213. doi: 10.1038/leu.2016.147. Epub 2016 May 23.
PubMed 27211270Minnie SA, Hill GR. Immunotherapy of multiple myeloma. J Clin Invest. 2020 Apr 1;130(4):1565-1575. doi: 10.1172/JCI129205.
PubMed 32149732An G, Li Z, Tai YT, Acharya C, Li Q, Qin X, Yi S, Xu Y, Feng X, Li C, Zhao J, Shi L, Zang M, Deng S, Sui W, Hao M, Zou D, Zhao Y, Qi J, Cheng T, Ru K, Wang J, Anderson KC, Qiu L. The impact of clone size on the prognostic value of chromosome aberrations by fluorescence in situ hybridization in multiple myeloma. Clin Cancer Res. 2015 May 1;21(9):2148-56. doi: 10.1158/1078-0432.CCR-14-2576. Epub 2015 Feb 4.
PubMed 25652456An G, Acharya C, Feng X, Wen K, Zhong M, Zhang L, Munshi NC, Qiu L, Tai YT, Anderson KC. Osteoclasts promote immune suppressive microenvironment in multiple myeloma: therapeutic implication. Blood. 2016 Sep 22;128(12):1590-603. doi: 10.1182/blood-2016-03-707547. Epub 2016 Jul 14.
PubMed 27418644Riccardi A, Mora O, Tinelli C, Porta C, Danova M, Brugnatelli S, Grasso D, Tolca B, Spanedda R, De Paoli A, Barbarano L, Cavanna L, Giordano M, Delfini C, Nicoletti G, Bergonzi C, Rinaldi E, Piccinini L, Ascari E. Response to first-line chemotherapy and long-term survival in patients with multiple myeloma: results of the MM87 prospective randomised protocol. Eur J Cancer. 2003 Jan;39(1):31-7. doi: 10.1016/s0959-8049(02)00529-4.
PubMed 12504655Durie BG, Jacobson J, Barlogie B, Crowley J. Magnitude of response with myeloma frontline therapy does not predict outcome: importance of time to progression in southwest oncology group chemotherapy trials. J Clin Oncol. 2004 May 15;22(10):1857-63. doi: 10.1200/JCO.2004.05.111. Epub 2004 Apr 26.
PubMed 15111617Chinese Hematology Association; Chinese Society of Hematology. [Guidelines for the diagnosis and management of multiple myeloma in China (2022 revision)]. Zhonghua Nei Ke Za Zhi. 2022 May 1;61(5):480-487. doi: 10.3760/cma.j.cn112138-20220309-00165. Chinese.
PubMed 35488597Overdijk MB, Verploegen S, Bogels M, van Egmond M, Lammerts van Bueren JJ, Mutis T, Groen RW, Breij E, Martens AC, Bleeker WK, Parren PW. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015;7(2):311-21. doi: 10.1080/19420862.2015.1007813.
PubMed 25760767Taylor RP, Lindorfer MA. Cytotoxic mechanisms of immunotherapy: Harnessing complement in the action of anti-tumor monoclonal antibodies. Semin Immunol. 2016 Jun;28(3):309-16. doi: 10.1016/j.smim.2016.03.003. Epub 2016 Mar 19.
PubMed 27009480Nijhof IS, Groen RW, Noort WA, van Kessel B, de Jong-Korlaar R, Bakker J, van Bueren JJ, Parren PW, Lokhorst HM, van de Donk NW, Martens AC, Mutis T. Preclinical Evidence for the Therapeutic Potential of CD38-Targeted Immuno-Chemotherapy in Multiple Myeloma Patients Refractory to Lenalidomide and Bortezomib. Clin Cancer Res. 2015 Jun 15;21(12):2802-10. doi: 10.1158/1078-0432.CCR-14-1813. Epub 2014 Nov 14.
PubMed 25398450Krejcik J, Casneuf T, Nijhof IS, Verbist B, Bald J, Plesner T, Syed K, Liu K, van de Donk NW, Weiss BM, Ahmadi T, Lokhorst HM, Mutis T, Sasser AK. Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood. 2016 Jul 21;128(3):384-94. doi: 10.1182/blood-2015-12-687749. Epub 2016 May 24.
PubMed 27222480van de Donk NWCJ, Usmani SZ. CD38 Antibodies in Multiple Myeloma: Mechanisms of Action and Modes of Resistance. Front Immunol. 2018 Sep 20;9:2134. doi: 10.3389/fimmu.2018.02134. eCollection 2018.
PubMed 30294326Voorhees PM, Kaufman JL, Laubach J, Sborov DW, Reeves B, Rodriguez C, Chari A, Silbermann R, Costa LJ, Anderson LD Jr, Nathwani N, Shah N, Efebera YA, Holstein SA, Costello C, Jakubowiak A, Wildes TM, Orlowski RZ, Shain KH, Cowan AJ, Murphy S, Lutska Y, Pei H, Ukropec J, Vermeulen J, de Boer C, Hoehn D, Lin TS, Richardson PG. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial. Blood. 2020 Aug 20;136(8):936-945. doi: 10.1182/blood.2020005288.
PubMed 32325490Palumbo 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 27557302McKeage K. Daratumumab: First Global Approval. Drugs. 2016 Feb;76(2):275-81. doi: 10.1007/s40265-015-0536-1.
PubMed 26729183
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Open and Non-interference Observational Clinical Study of Daratumumab, Pomalidomide and Dexamethasone (Dara-PD) in the Treatment of Patients With First Relapse of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06252792
- Acronym / sponsor ID
- First relapse multiple myeloma
- Conditions
- Multiple Myeloma, First Relapse
- Keywords
- Multiple Myeloma, First relapse, the second progression free survival time (PFS2)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- FengYan JinUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Hebei University, Second Hospital of Shanxi Medical University, Shandong Cancer Hospital and Institute, First Affiliated Hospital of Jinan University, Sun Yat-Sen University Cancer Center
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 12 Feb 2024 (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.
At present, there is no prospective study on the treatment of first-relapsed multiple myeloma with daratumumab plus pomalidomide and dexamethasone (Dara-Pd). A prospective, multicenter, open, non-interventional, observational clinical study to evaluate the efficacy and safety of Dara-Pd in patients with first relapse multiple myeloma.
Detailed description
To evaluate the impact of daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma. Among them, the second progression free survival time (PFS2) is defined as the time from enrollment to disease progression or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| daratumumab, pomalidomide, and dexamethasone (Dara-PD) | – | –the first relapse of patients who received daratumumab, pomalidomide, and dexamethasone (Dara-PD) treatment |
| other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) | – | –the first relapse of patients who received other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the first relapse of multiple myeloma
Key inclusion criteria (9 listed)
- Subjects will be enrolled in this study only if they met all of the following inclusion criteria.
- Age 18 years or older, regardless of gender.
- Diagnosis of symptomatic multiple myeloma based on the 2014 IMWG diagnostic criteria and the presence of measurable disease
- First relapse of multiple myeloma;
- Receiving first-line anti-multiple myeloma therapy;
Key exclusion criteria (7 listed)
- Diagnosis of inactive multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance) or smoldering myeloma.
- Relapsed and refractory myeloma：Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course；
- Primary refractory myeloma：Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy；
- Subject has received daratumumab or pomalidomide previously；
- Subject has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions is malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the second progression free survival time (PFS2)
Time frame: through study completion, up to 2 years
daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: through study completion, up to 2 years
Deep response rate (≥ VGPR)
Time frame: through study completion, up to 2 years
MRD negative
Time frame: through study completion, up to 2 years
continuous MRD negative rate
Time frame: through study completion, up to 2 years
Overall survival (OS)
Time frame: through study completion, up to 2 years
Evaluation of duration of remission (DOR)
Time frame: through study completion, up to 2 years
Treatment related adverse event(AE)
Time frame: From enrollment through follow-up (up to 24 months).
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 3 Apr 2026.
- Background: PubMed 27211270Majithia N, Rajkumar SV, Lacy MQ, Buadi FK, Dispenzieri A, Gertz MA, Hayman SR, Dingli D, Kapoor P, Hwa L, Lust JA, Russell SJ, Go RS, Kyle RA, Kumar SK. Early relapse following initial therapy for multiple myeloma predicts poor outcomes in the era of novel agents. Leukemia. 2016 Nov;30(11):2208-2213. doi: 10.1038/leu.2016.147. Epub 2016 May 23.
- Background: PubMed 32149732Minnie SA, Hill GR. Immunotherapy of multiple myeloma. J Clin Invest. 2020 Apr 1;130(4):1565-1575. doi: 10.1172/JCI129205.
- Background: PubMed 25652456An G, Li Z, Tai YT, Acharya C, Li Q, Qin X, Yi S, Xu Y, Feng X, Li C, Zhao J, Shi L, Zang M, Deng S, Sui W, Hao M, Zou D, Zhao Y, Qi J, Cheng T, Ru K, Wang J, Anderson KC, Qiu L. The impact of clone size on the prognostic value of chromosome aberrations by fluorescence in situ hybridization in multiple myeloma. Clin Cancer Res. 2015 May 1;21(9):2148-56. doi: 10.1158/1078-0432.CCR-14-2576. Epub 2015 Feb 4.
- Background: PubMed 27418644An G, Acharya C, Feng X, Wen K, Zhong M, Zhang L, Munshi NC, Qiu L, Tai YT, Anderson KC. Osteoclasts promote immune suppressive microenvironment in multiple myeloma: therapeutic implication. Blood. 2016 Sep 22;128(12):1590-603. doi: 10.1182/blood-2016-03-707547. Epub 2016 Jul 14.
- Background: PubMed 12504655Riccardi A, Mora O, Tinelli C, Porta C, Danova M, Brugnatelli S, Grasso D, Tolca B, Spanedda R, De Paoli A, Barbarano L, Cavanna L, Giordano M, Delfini C, Nicoletti G, Bergonzi C, Rinaldi E, Piccinini L, Ascari E. Response to first-line chemotherapy and long-term survival in patients with multiple myeloma: results of the MM87 prospective randomised protocol. Eur J Cancer. 2003 Jan;39(1):31-7. doi: 10.1016/s0959-8049(02)00529-4.
- Background: PubMed 15111617Durie BG, Jacobson J, Barlogie B, Crowley J. Magnitude of response with myeloma frontline therapy does not predict outcome: importance of time to progression in southwest oncology group chemotherapy trials. J Clin Oncol. 2004 May 15;22(10):1857-63. doi: 10.1200/JCO.2004.05.111. Epub 2004 Apr 26.
- Background: PubMed 35488597Chinese Hematology Association; Chinese Society of Hematology. [Guidelines for the diagnosis and management of multiple myeloma in China (2022 revision)]. Zhonghua Nei Ke Za Zhi. 2022 May 1;61(5):480-487. doi: 10.3760/cma.j.cn112138-20220309-00165. Chinese.
- Background: PubMed 25760767Overdijk MB, Verploegen S, Bogels M, van Egmond M, Lammerts van Bueren JJ, Mutis T, Groen RW, Breij E, Martens AC, Bleeker WK, Parren PW. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015;7(2):311-21. doi: 10.1080/19420862.2015.1007813.
- Background: PubMed 27009480Taylor RP, Lindorfer MA. Cytotoxic mechanisms of immunotherapy: Harnessing complement in the action of anti-tumor monoclonal antibodies. Semin Immunol. 2016 Jun;28(3):309-16. doi: 10.1016/j.smim.2016.03.003. Epub 2016 Mar 19.
- Background: PubMed 25398450Nijhof IS, Groen RW, Noort WA, van Kessel B, de Jong-Korlaar R, Bakker J, van Bueren JJ, Parren PW, Lokhorst HM, van de Donk NW, Martens AC, Mutis T. Preclinical Evidence for the Therapeutic Potential of CD38-Targeted Immuno-Chemotherapy in Multiple Myeloma Patients Refractory to Lenalidomide and Bortezomib. Clin Cancer Res. 2015 Jun 15;21(12):2802-10. doi: 10.1158/1078-0432.CCR-14-1813. Epub 2014 Nov 14.
- Background: PubMed 27222480Krejcik J, Casneuf T, Nijhof IS, Verbist B, Bald J, Plesner T, Syed K, Liu K, van de Donk NW, Weiss BM, Ahmadi T, Lokhorst HM, Mutis T, Sasser AK. Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood. 2016 Jul 21;128(3):384-94. doi: 10.1182/blood-2015-12-687749. Epub 2016 May 24.
- Background: PubMed 30294326van de Donk NWCJ, Usmani SZ. CD38 Antibodies in Multiple Myeloma: Mechanisms of Action and Modes of Resistance. Front Immunol. 2018 Sep 20;9:2134. doi: 10.3389/fimmu.2018.02134. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and First Relapse, run by FengYan Jin at 1 site in China.
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 9 inclusion and 7 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the second progression free survival time (PFS2) (time frame: through study completion, up to 2 years). 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 NCT06252792, which also lists 27 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 3 Apr 2026.