Multiple MyelomaPhase 2NCT03104842
Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone
A Phase 2 study testing Isatuximab, Carfilzomib and Lenalidomide in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 17 sites in Germany.
Trial summary
A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma paTients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Isatuximab, Carfilzomib and Lenalidomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 17 sitesGermany
- Study dates
- 15 Aug 2017to Sep 2026
- 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
- Subjects must have newly diagnosed, untreated, symptomatic (according to the revised CRAB criteria 2014), documented myeloma and have measurable disease (serum M-protein ≥ 1 g/dL (for IgA ≥ 0.5 g/dL) or urine M-protein ≥ 200 mg/24 hours) or in case of oligosecretory myeloma: involved FLC level ≥ 10 mg/dl, provided sFLC ratio is abnormal or in case of asecretory myeloma: > 1 focal lesions measurable by MRI
- Subjects must have high-risk myeloma defined as followed:
- Presence of one or more of the following cytogenetic abnormalities (determined by FISH):
- Del(17p) in ≥ 10% of purified cells
- t(4;14)
- ≥ 3 copies +1q21
Show all 20Show fewer
- t(14;16)
- ISS Stage II or III (all patients)
- FISH analysis of external laboratories other than Heidelberg is accepted, a list of laboratories will be filed in the study central.
- Must be ≥ 18 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements in the investigators opinion.
- WHO performance status 0-3 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions)
- Females of childbearing potential (FCBP) (1) must agree to refrain from becoming pregnant for 28 days prior to initiation of study drug, while on study drug and for 150 days* after discontinuation from the study drug by using 2 reliable methods of contraception and must agree to regular pregnancy testing during this timeframe.
- A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months) 3) has achieved menarche at some point.
- Females must agree to abstain from breastfeeding during study participation and 30 days* after study drug discontinuation.
- Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 150 days* following discontinuation from this study, even if he has undergone a successful vasectomy.
- Males must also agree to refrain from donating semen or sperm while on treatment with any study drug and for 150 days* after discontinuation from this study treatment.
- All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
- All subjects must agree not to share medication.
- All participating subjects have to follow the requirements of the Lenalidomide Pregnancy Prevention Plan
Who cannot join
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize Carfilzomib), mannitol, sucrose, histidine (as base and hydrochloride salt) and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
- Patients with known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
- Administration of systemic chemotherapy, biological, immunotherapy or any investigational agent (therapeutic or diagnostic) for multiple myeloma except bisphosphonate therapy. Emergency treatment with dexamethasone is allowed when the cumulative dexamethasone dose is less or equal 160 mg. It is allowed to include patients in the trial after 1 cycle (4 weeks) of any anti-myeloma first-line treatment.
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) < 1,000/μL, unless related to myeloma
- Platelet count < 30,000/ μL (in case of platelets < 50.000 /µl and ≥ 30.000 /µl myeloma bone marrow infiltration should be ≥ 50%)
Show all 24Show fewer
- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L); or free ionized calcium > 6.5 mg/dL (> 1.6 mmol/L)
- Serum GOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) or serum total bilirubin > 2.0 mg/dL if not due to hereditary abnormalities as Gilbert's disease or hereditary hemolysis (Note: if the mentioned limits for bilirubin or ASAT/ALAT are exceeded, but there is no significant hepatic dysfunction at investigator's discretion, the study office has to be consulted prior to inclusion)
- Patients with severe renal impairment (eGFR < 30 ml/min/1.73 m², MDRD formula or CDK-EPI or Creatinine Clearance < 30 ml/min)
- Active congestive heart failure (NYHA Class III to IV), symptomatic cardiac ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior study entry.
- Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B sAg and core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).
- Acute active, uncontrolled infection
- Significant neuropathy (Grades 3 to 4, or Grade 2 with pain according CTC V4.03)
- Second malignancy within the past 5 years except:
- adequately treated basal cell or squamous cell skin cancer
- carcinoma in situ of the cervix
- prostate cancer Gleason Score ≤ 6 with stable PSA over the past 12 months
- breast carcinoma in situ with full surgical resection
- treated medullary or papillary thyroid cancer
- Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to study entry.
- Major surgery within 4 weeks prior to cycle 1 day 1 (kyphoplasty is not considered major surgery); subjects should have been fully recovered from any surgical related toxicities.
- Female patients who are pregnant or lactating
- Any other clinically significant medical disease or psychiatric condition that, in the Investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent.
- Participation in any other clinical trial (with the exclusion of observational, non-interventional studies))
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Germany17 sites
Vivantes Am Urban
Berlin, 10967
Campus Benjamin Franklin Charite Berlin
Berlin
Vivantes Klinikum Neukölln
Berlin
Städt. Kliniken Bielefeld Klinikum Mitte
Bielefeld
Johanniter-Krankenhaus Bonn
Bonn, 53113
Uniklinikum Chemnitz
Chemnitz
Uniklinik Köln
Cologne
St. Antonius Hospital
Eschweiler
Universitätsklinikum Essen
Essen
Asklepios Altona
Hamburg
University Hospital Hamburg Eppendorf
Hamburg
University Hospital Heidelberg
Heidelberg
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, D-55131
Philipps-Universität Marburg
Marburg, 35032
Kliniken Maria Hilf GmbH, Klinik für Hämatologie, Onkologie und Gastroenterologie
Mönchengladbach, 41063
Klinikum Osnabrück
Osnabrück
Universitätsklinikum Tuebingen
Tübingen
About this study
Official title: Clinical Phase II, Multicenter, Open-label Study Evaluating iNduction, Consolidation and Maintenance With Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary Diagnosed High-risk Multiple Myeloma paTients
A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma paTients
- Conditions
- Multiple Myeloma
- Being tested
- Isatuximab, Carfilzomib, Lenalidomide, Dexamethasone
- Keywords
- Cytogenetic High-Risk
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsatuximabDrug
Antibody Intravenous
CarfilzomibDrug
Intravenous
LenalidomideDrug
Capsel
DexamethasoneDrug
Capsel
| Study group | Role | What they receive |
|---|---|---|
| Arm A Transplantation | Experimental | Patients ≤ 70 years of age and eligible for stem cell transplantation will enter study arm A They will undergo 6 cycles of Induction Treatment : Carfilzomib, Lenalidomid, Isatuximab (I-KRd), after intensification another 4 cycles of I-KRd as consolidation will be followed by IKR maintenance until PD or Toxicity Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone |
| Arm B No-Transplantation | Experimental | Patients > 70 years or ineligible for stem cell transplantation will enter study arm B They will undergo 12 cycles of Treatment : Carfilzomib, Lenalidomid, Isatuximab (I-KRd) (6 Cycles Induction, 2 Cycles Intensification, 4 Cycles Consolidation),to be followed by I-KR maintenance util PD or Toxicity Receives: Drug: Isatuximab; Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD negativity
MRD negativity (8-color flow, Euro-Flow plus Black Swan Panel)
Measured: after consolidation , an average of 1 year from first dosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start15 Aug 2017
- Primary completionMay 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katja Weisel, Prof, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104842
- Sponsor's protocol ID
- GMMG-CONCEPT
- Status last verified
- May 2026
- First submitted
- 29 Mar 2017
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leypoldt LB, Besemer B, Asemissen AM, Hanel M, Blau IW, Gorner M, Ko YD, Reinhardt HC, Staib P, Mann C, Lutz R, Munder M, Graeven U, Peceny R, Salwender H, Jauch A, Zago M, Benner A, Tichy D, Bokemeyer C, Goldschmidt H, Weisel KC. Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of high-risk multiple myeloma: interim analysis of the GMMG-CONCEPT trial. Leukemia. 2022 Mar;36(3):885-888. doi: 10.1038/s41375-021-01431-x. Epub 2021 Nov 3. No abstract available.
PubMed 34732857Leypoldt LB, Tichy D, Besemer B, Hanel M, Raab MS, Mann C, Munder M, Reinhardt HC, Nogai A, Gorner M, Ko YD, de Wit M, Salwender H, Scheid C, Graeven U, Peceny R, Staib P, Dieing A, Einsele H, Jauch A, Hundemer M, Zago M, Pozek E, Benner A, Bokemeyer C, Goldschmidt H, Weisel KC. Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone for the Treatment of High-Risk Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2024 Jan 1;42(1):26-37. doi: 10.1200/JCO.23.01696. Epub 2023 Sep 27.
PubMed 37753960Leypoldt LB, Tichy D, Besemer B, Hanel M, Raab MS, Mann C, Munder M, Reinhardt HC, Nogai A, Gorner M, Ko YD, de Wit M, Salwender H, Scheid C, Graeven U, Peceny R, Staib P, Dieing A, Einsele H, Jauch A, Hundemer M, Zago M, Pozek E, Benner A, Bokemeyer C, Goldschmidt H, Weisel KC. Plain language summary of isatuximab plus carfilzomib, lenalidomide, and dexamethasone for the treatment of people with high-risk newly diagnosed multiple myeloma. Future Oncol. 2024 Dec;20(39):3193-3207. doi: 10.1080/14796694.2024.2402639. Epub 2024 Sep 30.
PubMed 39345094Oliva S, Kaiser MF. Is it time to tailor treatment on the basis of minimal residual disease in multiple myeloma? Lancet Haematol. 2021 Dec;8(12):e876-e877. doi: 10.1016/S2352-3026(21)00341-0. No abstract available.
PubMed 34826409Pawlyn C. High-risk myeloma: a challenge to define and to determine the optimal treatment. Lancet Haematol. 2021 Jan;8(1):e4-e6. doi: 10.1016/S2352-3026(20)30361-6. Epub 2020 Dec 22. No abstract available.
PubMed 33357481
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phase II, Multicenter, Open-label Study Evaluating iNduction, Consolidation and Maintenance With Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary Diagnosed High-risk Multiple Myeloma paTients
- ClinicalTrials.gov ID
- NCT03104842
- Acronym / sponsor ID
- GMMG-CONCEPT
- Conditions
- Multiple Myeloma
- Keywords
- Cytogenetic High-Risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Apr 2017 (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.
A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma paTients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A Transplantation | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Lenalidomide, Drug: DexamethasonePatients ≤ 70 years of age and eligible for stem cell transplantation will enter study arm A They will undergo 6 cycles of Induction Treatment : Carfilzomib, Lenalidomid, Isatuximab (I-KRd), after intensification another 4 cycles of I-KRd as consolidation will be followed by IKR maintenance until PD or Toxicity |
| Arm B No-Transplantation | Experimental | Drug: Isatuximab, Drug: Carfilzomib, Drug: Lenalidomide, Drug: DexamethasonePatients > 70 years or ineligible for stem cell transplantation will enter study arm B They will undergo 12 cycles of Treatment : Carfilzomib, Lenalidomid, Isatuximab (I-KRd) (6 Cycles Induction, 2 Cycles Intensification, 4 Cycles Consolidation),to be followed by I-KR maintenance util PD or Toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subjects must have newly diagnosed, untreated, symptomatic (according to the revised CRAB criteria 2014), documented myeloma and have measurable disease (serum M-protein ≥ 1 g/dL (for IgA ≥ 0.5 g/dL) or urine M-protein ≥ 200 mg/24 hours) or in case of oligosecretory myeloma: involved FLC level ≥ 10 mg/dl, provided sFLC ratio is abnormal or in case of asecretory myeloma: > 1 focal lesions measurable by MRI
- Must be ≥ 18 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements in the investigators opinion.
- WHO performance status 0-3 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions)
- Females of childbearing potential (FCBP) (1) must agree to refrain from becoming pregnant for 28 days prior to initiation of study drug, while on study drug and for 150 days* after discontinuation from the study drug by using 2 reliable methods of contraception and must agree to regular pregnancy testing during this timeframe.
Key exclusion criteria (24 listed)
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize Carfilzomib), mannitol, sucrose, histidine (as base and hydrochloride salt) and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
- Patients with known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
- Administration of systemic chemotherapy, biological, immunotherapy or any investigational agent (therapeutic or diagnostic) for multiple myeloma except bisphosphonate therapy. Emergency treatment with dexamethasone is allowed when the cumulative dexamethasone dose is less or equal 160 mg. It is allowed to include patients in the trial after 1 cycle (4 weeks) of any anti-myeloma first-line treatment.
- Any of the following laboratory abnormalities:
- Active congestive heart failure (NYHA Class III to IV), symptomatic cardiac ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior study entry.
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 |
|---|---|---|
| IsatuximabAntibody Intravenous | Drug | Arm A Transplantation, Arm B No-Transplantation |
| CarfilzomibIntravenous | Drug | Arm A Transplantation, Arm B No-Transplantation |
| LenalidomideCapsel | Drug | Arm A Transplantation, Arm B No-Transplantation |
| DexamethasoneCapsel | Drug | Arm A Transplantation, Arm B No-Transplantation |
Primary outcome
MRD negativity
Time frame: after consolidation , an average of 1 year from first dosis
MRD negativity (8-color flow, Euro-Flow plus Black Swan Panel)
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 15 May 2026.
- Results publication: PubMed 34732857Leypoldt LB, Besemer B, Asemissen AM, Hanel M, Blau IW, Gorner M, Ko YD, Reinhardt HC, Staib P, Mann C, Lutz R, Munder M, Graeven U, Peceny R, Salwender H, Jauch A, Zago M, Benner A, Tichy D, Bokemeyer C, Goldschmidt H, Weisel KC. Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of high-risk multiple myeloma: interim analysis of the GMMG-CONCEPT trial. Leukemia. 2022 Mar;36(3):885-888. doi: 10.1038/s41375-021-01431-x. Epub 2021 Nov 3. No abstract available.
- Results publication: PubMed 37753960Leypoldt LB, Tichy D, Besemer B, Hanel M, Raab MS, Mann C, Munder M, Reinhardt HC, Nogai A, Gorner M, Ko YD, de Wit M, Salwender H, Scheid C, Graeven U, Peceny R, Staib P, Dieing A, Einsele H, Jauch A, Hundemer M, Zago M, Pozek E, Benner A, Bokemeyer C, Goldschmidt H, Weisel KC. Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone for the Treatment of High-Risk Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2024 Jan 1;42(1):26-37. doi: 10.1200/JCO.23.01696. Epub 2023 Sep 27.
- Derived from this study: PubMed 39345094Leypoldt LB, Tichy D, Besemer B, Hanel M, Raab MS, Mann C, Munder M, Reinhardt HC, Nogai A, Gorner M, Ko YD, de Wit M, Salwender H, Scheid C, Graeven U, Peceny R, Staib P, Dieing A, Einsele H, Jauch A, Hundemer M, Zago M, Pozek E, Benner A, Bokemeyer C, Goldschmidt H, Weisel KC. Plain language summary of isatuximab plus carfilzomib, lenalidomide, and dexamethasone for the treatment of people with high-risk newly diagnosed multiple myeloma. Future Oncol. 2024 Dec;20(39):3193-3207. doi: 10.1080/14796694.2024.2402639. Epub 2024 Sep 30.
- Derived from this study: PubMed 34826409Oliva S, Kaiser MF. Is it time to tailor treatment on the basis of minimal residual disease in multiple myeloma? Lancet Haematol. 2021 Dec;8(12):e876-e877. doi: 10.1016/S2352-3026(21)00341-0. No abstract available.
- Derived from this study: PubMed 33357481Pawlyn C. High-risk myeloma: a challenge to define and to determine the optimal treatment. Lancet Haematol. 2021 Jan;8(1):e4-e6. doi: 10.1016/S2352-3026(20)30361-6. Epub 2020 Dec 22. No abstract available.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Katja Weisel, Prof principal investigator
Universitätsklinikum Hamburg-Eppendorf
17 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 Isatuximab, Carfilzomib and Lenalidomide in people with Multiple Myeloma, run by Universitätsklinikum Hamburg-Eppendorf at 17 sites in Germany.
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 20 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD negativity (time frame: after consolidation , an average of 1 year from first dosis). 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 NCT03104842, which also lists 5 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 15 May 2026.