Multiple MyelomaPhase 2NCT04140162
Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy
A Phase 2 study testing Daratumumab, Lenalidomide and Bortezomib in people with Multiple Myeloma, run by University of Michigan Rogel Cancer Center at 4 sites in United States.
Trial summary
This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative… 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?
- Daratumumab, Lenalidomide and Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Oct 2020to 2 Sep 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants ≥18 years of age or legal age of consent per local regulations (whichever is greater).
- Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
- ECOG status (Appendix A) of ≤2 and able to tolerate all applicable treatments per investigator's evaluation and standard institutional criteria.
- Both transplant eligible and ineligible myeloma patients can be included in this study. If applicable, participant should be able to tolerate all treatments per investigator's evaluation, including high-dose chemotherapy and autologous stem cell transplant (ASCT) based on standard criteria at the institution where this treatment will be administered.
- Participant must have a diagnosis of active MM according to International Myeloma Working Group (IMWG) diagnostic criteria.
- Participant must also have measurable disease per protocol.
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- Baseline bone marrow or tissue sample available for Clonality ID in ClonoSEQ
- Participant must be registered in and must comply with all requirements of REMSTM program for lenalidomide.
- Female participant who:
- Is post-menopausal for at least one year prior to study enrollment, OR
- Is surgically sterile, OR
- If of childbearing potential, must have a negative urine or serum pregnancy test within 10-14 days prior to and again within 24 hours of starting lenalidomide. They must also be willing to use TWO effective forms of contraception simultaneously from the time of signing the study consent until 90 days following the administration of the last dose of lenalidomide and 7 months following the administration of the last dose of bortezomib, OR
- Agree to practice complete abstinence if that is aligned with their lifestyle, which does not include periodic abstinence or withdrawal.
- Male participant, even if surgically sterilized, must agree to one of the following:
- Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of lenalidomide and 4 months following the administration of the last dose of bortezomib, OR
- Agree to practice complete abstinence if that is aligned with their lifestyle, which does not include periodic abstinence or withdrawal.
Who cannot join
- Diagnoses of smoldering MM (SMM), monoclonal gammopathy of undetermined significance (MGUS), non-secretory MM, plasma cell leukemia, AL amyloidosis, Waldenstrom's. macroglobulinemia, POEMS syndrome. History of SMM and/or MGUS is not excluded.
- Known disease involvement of the CNS.
- History of prior hematopoietic stem cell transplant of any type.
- Received more than one cycle of anti-myeloma therapy prior to enrollment. Up to one cycle of myeloma therapy is allowed. Concomitant treatment is allowed with low-dose corticosteroids and bisphosphonates. The dose of corticosteroids for myeloma treatment should not exceed the equivalent of 160 mg of dexamethasone over a two-week period before initiation of protocol. Prednisone up to but no more than 10 mg po daily or its equivalent is allowed, for symptom management and comorbid conditions.
- Significant renal insufficiency, defined as creatinine clearance <30ml/min per Cockcroft-Gault formula.
- Hepatic impairment, defined as bilirubin >1.5 x institutional upper limit of normal (ULN) or AST (SGOT), ALT (SGPT), or alkaline phosphatase > 3x institutional ULN.
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- Absolute neutrophil count (ANC) < 1000 cells/mm3 within 14 days of enrollment. Growth factor may not be used to meet ANC eligibility criteria.
- Hemoglobin (Hgb) < 8g/dL within 7 days of enrollment.
- Platelet count < 75,000 cells/mm3 within 7 days of enrollment. Transfusion may not be used to meet platelet eligibility criteria.
- Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if subject were to participate in the study.
- Major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from complications of the surgery.
- Clinically significant peripheral neuropathy not well controlled with treatment, defined as symptoms limiting activities of daily living (basic ADLs).
- Symptomatic uncontrolled cardiac disease including congestive heart failure with New York Heart Association class III-IV symptoms, arrhythmia, unstable angina or myocardial infarction within the past six months, or any other uncontrolled or severe cardiovascular condition.
- Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal.
- Clinically uncontrolled asthma of any classification or known moderate or severe persistent asthma within the past two years (see asthma guidelines. https://www.nhlbi.nih.gov/files/docs/guidelines/asthma_qrg.pdf).
- Serious intercurrent illness including but not limited to clinically relevant cerebrovascular disease, uncontrolled diabetes mellitus, cirrhosis, pulmonary disease.
- Active autoimmune process or other disease requiring systemic immunosuppressive, monoclonal antibody, small molecule, or radiation therapy. However local radiation for myeloma related symptomatic treatment is allowed
- Participant is:
- Seropositive for HIV
- Seropositive for Hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]
- Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded.
- Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
- Seropositive for Hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
- History of additional active malignancy in the past five years (not including squamous cell or basal cell carcinoma of the skin or in situ cervical cancer). However, malignancy treated with curative intent with <5% chance of disease relapse / recurrence in the next two years is allowed.
- Known contraindication to study required medications (including steroids) or appropriate prophylactic medications (e.g. acyclovir, aspirin, warfarin or low-molecular weight heparin).
- Women with a positive pregnancy test during the screening period prior to study initiation or who are lactating.
- Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
- Any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given.
- Participants using strong CYP3A4 inducers are excluded unless the inducer can be switched to an alternative agent while receiving Bortezomib (per protocol).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
University of Texas Southwestern -- Simmons Comprehensive Cancer Center
Dallas, Texas, 75390
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Rochester
Rochester, New York, 14642
About this study
This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy.
This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.
- Conditions
- Multiple Myeloma
- Being tested
- Daratumumab, Lenalidomide, Bortezomib, Dexamethasone
- Keywords
- Dara-R, DaraRd, Dara-RVd, MRD
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).
Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36)
Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88)
Sites will continue to use IV daratumumab to treat existing study patients until the IV daratumumab stock on site has been exhausted. The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab.
Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1
LenalidomideDrug
Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24)
Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36)
Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance
Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression
BortezomibDrug
Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36)
DexamethasoneDrug
Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
| Study group | Role | What they receive |
|---|---|---|
| Dara-Rd followed by Dara-RVd | Experimental | * Induction regimen with Daratumumab, Lenalidomide and Dexamethasone (Dara-Rd) in all study subjects, weeks 1-24
* Consolidation regimen with Daratumumab, Lenalidomide, Bortezomib and Dexamethasone (Dara-RVd) in post-induction MRD+ population, weeks 25-36
* Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88
* Maintenance regimen with lenalidomide (R) until progression or intolerance Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Achieve MRD Negativity Either After Induction or, if Still MRD-positive After Induction, After Consolidation.
Of participants who complete at least one cycle of induction therapy, proportion that achieve MRD-negativity after completion of induction + those who achieve MRD-negativity after completion of consolidation (if still MRD-positive after induction). MRD status determined by International Myeloma Working Group (IMWG) Response Criteria.
Measured: At the end of week 36 (post-consolidation therapy)
Secondary outcomes (10)
Overall Survival (OS)
Time from initiation of daratumumab-based combination regimen until death or last follow-up date (whichever occurs first).
Measured: Up to 3 years after start of study treatment
Progression-free Survival (PFS)
Time from initiation of daratumumab-based combination regimen to disease progression, where disease progression is according to the IMWG criteria, death, or last disease evaluation before the start of any subsequent anti-myeloma therapy (whichever occurs first).
Measured: Up to 3 years after start of study treatment
Proportion of Participants Who Were MRD-positive After Induction and Subsequently Achieve MRD-negative After Consolidation.
Of participants who are still MRD-positive after induction, proportion that achieve MRD-negative after consolidation. Per IMWG Response Criteria
Measured: At the end of week 36 (post-consolidation therapy)
Proportion of Participants Who Maintain Post-induction MRD-negativity to Post-consolidation
Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity through completion of consolidation therapy.
Measured: At the end of week 36 (post-consolidation therapy)
Proportion of Participants Who Maintain Post-induction MRD-negativity to Post-consolidation.
Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity through completion of 1 year of maintenance therapy.
Measured: At the end of week 88 (post 1 year of maintenance therapy)
Proportion of Participants Who Maintain Post-induction MRD-negativity to Last Follow-up Visit.
Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity until last follow-up visit (if after week 88).
Measured: After week 88, up to 3 years after start of study treatment
Health-related Quality of Life Assessment Changes From Baseline Using EuroQol Survey "EQ-5D."
EQ-5D is a standardized participant-reported outcome measure developed by the EuroQol Group and used in this trial to assess health-related quality of life.
Measured: Baseline to 16 weeks post-last-dose of study treatment (Dara, R, V or d)
Neurotoxicity Assessment Changes From Baseline Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Questionnaire.
The FACT/GOG-Ntx is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy, plus an eleven-item subscale (Ntx subscale) that evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy.
Measured: Baseline to 16 weeks post-last-dose of study treatment (Dara, R, V or d)
Incidence of Treatment-emergent Adverse Events
Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: From start of study treatment (Dara-Rd) up to 30 days post last dose of study treatment (Dara, R, V or d)
Proportion of Participants With a Successful Stem Cell Mobilization After Receiving Dara-based Induction Therapy.
Of participants who have stem cells collected, proportion who have enough CD34+ cells after mobilization to be able to proceed with an autologous stem cell transplant (ASCT) if needed. Successful mobilization for each participant will be based on standard criteria at the institution where the transplant will be administered.
Measured: At the end of week 24 (post-induction therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start5 Oct 2020
- Primary completion2 May 2024
- Study completion2 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Jing Ye, M.D., Study director, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140162
- Sponsor's protocol ID
- UMCC 2018.056
- Other IDs
- HUM00147751
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2019
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohan M, Gundarlapalli S, Szabo A, Yarlagadda N, Kakadia S, Konda M, Jillella A, Fnu A, Ogunsesan Y, Yarlagadda L, Thalambedu N, Munawar H, Graziutti M, Al Hadidi S, Alapat D, Thanendrarajan S, Zangari M, van Rhee F, Schinke C. Tandem autologous stem cell transplantation in patients with persistent bone marrow minimal residual disease after first transplantation in multiple myeloma. Am J Hematol. 2022 Jun 1;97(6):E195-E198. doi: 10.1002/ajh.26530. Epub 2022 Mar 21. No abstract available.
PubMed 35285981Mohan M, Hari P, Szabo A, Dhakal B, Chhabra S, D'Souza A. Long term follow up of newly diagnosed multiple myeloma patients treated with pembrolizumab consolidation post-autologous stem cell transplantation. Leuk Res. 2021 Oct;109:106648. doi: 10.1016/j.leukres.2021.106648. Epub 2021 Jun 23. No abstract available.
PubMed 34182226
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy
- ClinicalTrials.gov ID
- NCT04140162
- Acronym / sponsor ID
- UMCC 2018.056
- Conditions
- Multiple Myeloma
- Keywords
- Dara-R, DaraRd, Dara-RVd, MRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy.
This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dara-Rd followed by Dara-RVd | Experimental | Drug: Daratumumab, Drug: Lenalidomide, Drug: Bortezomib, Drug: Dexamethasone* Induction regimen with Daratumumab, Lenalidomide and Dexamethasone (Dara-Rd) in all study subjects, weeks 1-24 * Consolidation regimen with Daratumumab, Lenalidomide, Bortezomib and Dexamethasone (Dara-RVd) in post-induction MRD+ population, weeks 25-36 * Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88 * Maintenance regimen with lenalidomide (R) until progression or intolerance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants ≥18 years of age or legal age of consent per local regulations (whichever is greater).
- Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
- ECOG status (Appendix A) of ≤2 and able to tolerate all applicable treatments per investigator's evaluation and standard institutional criteria.
- Both transplant eligible and ineligible myeloma patients can be included in this study. If applicable, participant should be able to tolerate all treatments per investigator's evaluation, including high-dose chemotherapy and autologous stem cell transplant (ASCT) based on standard criteria at the institution where this treatment will be administered.
- Participant must have a diagnosis of active MM according to International Myeloma Working Group (IMWG) diagnostic criteria.
Key exclusion criteria (29 listed)
- Diagnoses of smoldering MM (SMM), monoclonal gammopathy of undetermined significance (MGUS), non-secretory MM, plasma cell leukemia, AL amyloidosis, Waldenstrom's. macroglobulinemia, POEMS syndrome. History of SMM and/or MGUS is not excluded.
- Known disease involvement of the CNS.
- History of prior hematopoietic stem cell transplant of any type.
- Received more than one cycle of anti-myeloma therapy prior to enrollment. Up to one cycle of myeloma therapy is allowed. Concomitant treatment is allowed with low-dose corticosteroids and bisphosphonates. The dose of corticosteroids for myeloma treatment should not exceed the equivalent of 160 mg of dexamethasone over a two-week period before initiation of protocol. Prednisone up to but no more than 10 mg po daily or its equivalent is allowed, for symptom management and comorbid conditions.
- Significant renal insufficiency, defined as creatinine clearance <30ml/min per Cockcroft-Gault formula.
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 |
|---|---|---|
| DaratumumabInduction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses). Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) Sites will continue to use IV daratumumab to treat existing study patients until the IV daratumumab stock on site has been exhausted. The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab. Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 | Drug | Dara-Rd followed by Dara-RVd |
| LenalidomideInduction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24) Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36) Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression | Drug | Dara-Rd followed by Dara-RVd |
| BortezomibConsolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) | Drug | Dara-Rd followed by Dara-RVd |
| DexamethasoneInduction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly | Drug | Dara-Rd followed by Dara-RVd |
Primary outcome
Proportion of Participants Who Achieve MRD Negativity Either After Induction or, if Still MRD-positive After Induction, After Consolidation.
Time frame: At the end of week 36 (post-consolidation therapy)
Of participants who complete at least one cycle of induction therapy, proportion that achieve MRD-negativity after completion of induction + those who achieve MRD-negativity after completion of consolidation (if still MRD-positive after induction). MRD status determined by International Myeloma Working Group (IMWG) Response Criteria.
10 secondary outcomes
Overall Survival (OS)
Time frame: Up to 3 years after start of study treatment
Progression-free Survival (PFS)
Time frame: Up to 3 years after start of study treatment
Proportion of Participants Who Were MRD-positive After Induction and Subsequently Achieve MRD-negative After Consolidation.
Time frame: At the end of week 36 (post-consolidation therapy)
Proportion of Participants Who Maintain Post-induction MRD-negativity to Post-consolidation
Time frame: At the end of week 36 (post-consolidation therapy)
Proportion of Participants Who Maintain Post-induction MRD-negativity to Post-consolidation.
Time frame: At the end of week 88 (post 1 year of maintenance therapy)
Proportion of Participants Who Maintain Post-induction MRD-negativity to Last Follow-up Visit.
Time frame: After week 88, up to 3 years after start of study treatment
Health-related Quality of Life Assessment Changes From Baseline Using EuroQol Survey "EQ-5D."
Time frame: Baseline to 16 weeks post-last-dose of study treatment (Dara, R, V or d)
Neurotoxicity Assessment Changes From Baseline Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Questionnaire.
Time frame: Baseline to 16 weeks post-last-dose of study treatment (Dara, R, V or d)
Incidence of Treatment-emergent Adverse Events
Time frame: From start of study treatment (Dara-Rd) up to 30 days post last dose of study treatment (Dara, R, V or d)
Proportion of Participants With a Successful Stem Cell Mobilization After Receiving Dara-based Induction Therapy.
Time frame: At the end of week 24 (post-induction therapy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35285981Mohan M, Gundarlapalli S, Szabo A, Yarlagadda N, Kakadia S, Konda M, Jillella A, Fnu A, Ogunsesan Y, Yarlagadda L, Thalambedu N, Munawar H, Graziutti M, Al Hadidi S, Alapat D, Thanendrarajan S, Zangari M, van Rhee F, Schinke C. Tandem autologous stem cell transplantation in patients with persistent bone marrow minimal residual disease after first transplantation in multiple myeloma. Am J Hematol. 2022 Jun 1;97(6):E195-E198. doi: 10.1002/ajh.26530. Epub 2022 Mar 21. No abstract available.
- Derived from this study: PubMed 34182226Mohan M, Hari P, Szabo A, Dhakal B, Chhabra S, D'Souza A. Long term follow up of newly diagnosed multiple myeloma patients treated with pembrolizumab consolidation post-autologous stem cell transplantation. Leuk Res. 2021 Oct;109:106648. doi: 10.1016/j.leukres.2021.106648. Epub 2021 Jun 23. 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.
Jing Ye, M.D. study director
MD Anderson
4 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, Lenalidomide and Bortezomib in people with Multiple Myeloma, run by University of Michigan Rogel Cancer Center at 4 sites in United States.
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 16 inclusion and 29 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 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants Who Achieve MRD Negativity Either After Induction or, if Still MRD-positive After Induction, After Consolidation. (time frame: At the end of week 36 (post-consolidation therapy)). 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 NCT04140162, which also lists 2 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 28 Jul 2026.