Multiple MyelomaPhase 2MASTER-2NCT05231629
Sequential Therapy in Multiple Myeloma Guided by MRD Assessments
A Phase 2 study testing Dara-VRd intensification, Dara-R maintenance, AHCT intensification, Dara-R maintenance and AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenance in people with Multiple Myeloma, run by University of Alabama at Birmingham at 10 sites in United States.
Trial summary
This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. 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?
- Dara-VRd intensification, Dara-R maintenance, AHCT intensification, Dara-R maintenance and AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Dec 2023to Dec 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
- Age>18 years with no upper age limit
- Newly diagnosed multiple myeloma with indication for initiation of therapy.
- ECOG performance status 0-2
- No prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bortezomib (up to 5.2 mg/m2) and/or cyclophosphamide up to 1000 mg/m2 and/or lenalidomide (up to 21 days of therapy) administered for no longer than 4 weeks prior to enrollment (pre induction). If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be available.
- Measurable disease meeting at least one of the following criteria (at screening or prior to pre induction):
- Serum monoclonal (M) protein ≥1.0 g/dl (≥0.5 g/dl if IgA, IgD, IgE or IgM multiple myeloma)
Show all 32Show fewer
- ≥ 200 mg of M protein/24h in the urine
- Difference between affected and unaffected free light chain ≥10 mg/dL with abnormal kappa to lambda ratio.
- Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment
- Hemoglobin ≥7 g/dL (≥4.65 mmol/L; without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted)
- Platelets ≥75×10^9/L in participants in whom <50% of bone marrow nucleated cells are plasma cells and ≥50×10^9/L in participants in whom
- 50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test)
- Absolute neutrophil count ≥1.0×109/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated G CSF)
- AST and ALT ≤2.5×ULN
- eGFR ≥30 mL/min based on Modified Diet in Renal Disease Formula calculation or creatine clearance measured by a 24-hour urine collection
- Total bilirubin ≤2.0×ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5×ULN is required)
- Serum calcium corrected for albumin ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)
- A woman of childbearing potential must have a negative highly-sensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study
- A woman must be
- Not of childbearing potential, or
- Of childbearing potential and
- Practicing true abstinence; or
- Have a sole partner who is vasectomized; or
- Practicing ≥1 highly-effective, user-independent method of contraception
- A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study treatment
- A man must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days after receiving the last dose of study treatment. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.
- Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
- Must sign an ICF (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- All participants must agree to comply with and be enrolled in Revlimid REMSTM program.
- All participants must meet institution-specific criteria for AHCT eligibility as assessed by the investigator.
- In line with the higher incidence of MM in Blacks, and to address the historical underrepresentation of ethnical minorities in MM trials, at least 25% of the enrolled patients will be of ethnical minorities.
Who cannot join
- Diagnosis of Plasma cell leukemia, primary light chain amyloidosis, POEMS, or Waldenstrom's macroglobulinemia.
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the teclistamab Investigator's Brochure and appropriate package inserts)
- Prior or concurrent exposure to any of the following:
- Teclistamab or any anti-BCMA therapy
- Daratumumab or any anti-CD38 therapy
- Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less
Show all 50Show fewer
- Investigational vaccine within 4 weeks
- Live, attenuated vaccine within 4 weeks before randomization.
- Radiotherapy within 14 days or focal radiation within 7 days
- Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
- Cytotoxic therapy within 14 days
- PI therapy within 14 days
- IMiD agent therapy within 14 days
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
- Myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are:
- Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured
- Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.
- Noninvasive cervical cancer treated within the last 24 months that is considered completely cured
- Localized prostate cancer (N0M0):
- With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance
- With a Gleason score of 3+4 that has been treated >6 months prior to full study screening and considered to have a very low risk of recurrence, or
- History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.
- Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence
- Other malignancy that is considered cured with minimal risk of recurrence
- Stroke or seizure within 6 months prior to signing ICF.
- Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is <50% of predicted normal.
- Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.
- Prior allogeneic bone marrow, hematopoietic stem cell or solid organ transplant.
- Participant is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study treatment.
- Participant plans to father a child while enrolled in this study or within 90 days after the last dose of study treatment.
- Presence of the following cardiac conditions:
- New York Heart Association stage III or IV congestive heart failure
- Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization
- History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
- History of severe non-ischemic cardiomyopathy
- Any of the following:
- Known to be seropositive for human immunodeficiency virus
- Hepatitis B infection (ie, HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status.
- Active hepatitis C infection as measured by positive HCV-RNA testing.
- Major surgery within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 21 days prior to registration.
- Contra indication or intolerance to required supportive care medications.
- Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:
- Uncontrolled diabetes
- Acute diffuse infiltrative pulmonary disease
- Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy
- History of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing
- Disabling psychiatric conditions (eg, alcohol or drug abuse), severe dementia, or altered mental status
- Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- History of non-compliance with recommended medical treatments
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Texas Southwestern
Dallas, Texas, 75390
Colorado Blood Cancer Institute
Denver, Colorado, 80218
University of Wisconsin - Carbone
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University
Nashville, Tennessee, 37232
Columbia University
New York, New York, 10032
Oregon Health and Science University
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84112
University of Washington
Seattle, Washington, 98109
About this study
Official title: MRD-Guided Sequential Therapy For Deep Response in Newly Diagnosed Multiple Myeloma - MASTER-2 Trial
This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow.
For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT).
For patients who are MRD "positive" at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD "negative" with AHCT plus teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab.
- Conditions
- Multiple Myeloma
- Being tested
- Dara-VRd intensification, Dara-R maintenance, AHCT intensification, Dara-R maintenance, AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenance, AHCT intensification, Dara-R consolidation, Dara-R maintenance, Dara-VRd induction
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dara-VRd intensification, Dara-R maintenanceDrug
Also called darzalex, velcade, revlimid, dexamethasone
Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort
- MRD negative cohort - Patients will be randomized between arm A (3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance) and arm B (AHCT intensification followed by 13 cycles of Dara-R maintenance) for intensification and maintenance
AHCT intensification, Dara-R maintenanceDrug
Also called melphalan, darzalex, revlimid
Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort
- MRD negative cohort - Patients will be randomized between arm A (3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance) and arm B (AHCT intensification followed by 13 cycles of Dara-R maintenance) for intensification and maintenance
AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenanceDrug
Also called melphalan, teclistamab, darzalex
Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort. MRD positive cohort - Patients will be randomized between arm C (AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance) and arm D (AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance) for intensification, consolidation and maintenance.
AHCT intensification, Dara-R consolidation, Dara-R maintenanceDrug
Also called melphalan, darzalex, revlimid
Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort. MRD positive cohort - Patients will be randomized between arm C (AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance) and arm D (AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance) for intensification, consolidation and maintenance.
Dara-VRd inductionDrug
Also called darzalex, velcade, revlimid, dexamethasone
Patients undergo induction therapy with 6 cycles of daratumumab, bortezomib, lenalidomide and dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance in MRD negative patients Receives: Drug: Dara-VRd intensification, Dara-R maintenance |
| Arm B | Active comparator | AHCT intensification followed by 13 cycles of Dara-R maintenance in MRD negative patients Receives: Drug: AHCT intensification, Dara-R maintenance |
| Arm C | Experimental | AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance in MRD positive patients Receives: Drug: AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenance |
| Arm D | Active comparator | AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance in MRD positive patients Receives: Drug: AHCT intensification, Dara-R consolidation, Dara-R maintenance |
| Arm M | Other | Induction - 6 cycles of Dara-VRd in all participants Receives: Drug: Dara-VRd induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of response obtained with 6 cycles of Dara-VRd
For the primary objective "for all patients" to describe the depth of response obtained with 6 cycles of Dara-VRd and the corresponding endpoint of MRD negativity at end of induction all patients with MRD evaluable
Measured: 6 months
Sustained MRD negativity
MRD <10-5 assessed before and after 13 cycles of maintenance
Measured: 18 months
Secondary outcomes (3)
Progression-free survival
Occurrence of disease progression or death
Measured: 60 months
Overall Survival
Occurrence of death regardless of cause
Measured: 60 months
Cumulative incidence of MRD resurgence or progression
Occurrence of MRD >= 10-5 or progression for patients starting observation with MRD surveillance (MRD-SURE) after achieving sustained MRD negativity.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start13 Dec 2023
- Primary completionSep 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Randomised
- Intervention model
- Sequential
- Model description
- Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon completion of induction, patients undergo MRD assessment by next-generation sequencing utilizing ClonoSEQ® (MRD1) and undergo mobilization and collection of autologous hematopoietic progenitor cells for future AHCT. Upon confirmation of adequate hematopoietic cell collection (≥2 x 10\^6 CD34+ cells/kg) and result of MRD1 patients will undergo randomization according to the MRD-assigned cohort * MRD negative cohort - Patients will be randomized between arm A and arm B for intensification and maintenance. * MRD positive cohort - Patients will be randomized between arm C and arm D for intensification, consolidation and maintenance.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Sarah Cannon, coMMit, Myeloma Trials, Innovated
- Responsible party
- Principal investigator, Luciano Jose Costa, MD, University of Alabama at Birmingham
- Investigators
- Luciano Costa, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231629
- Sponsor's protocol ID
- IRB-300008365 (UAB-21107)
- Other IDs
- 64007957MMY2005
- Acronym
- MASTER-2
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRD-Guided Sequential Therapy For Deep Response in Newly Diagnosed Multiple Myeloma - MASTER-2 Trial
- ClinicalTrials.gov ID
- NCT05231629
- Acronym / sponsor ID
- MASTER-2 / IRB-300008365 (UAB-21107)
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Sarah Cannon, coMMit, Myeloma Trials, Innovated
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 9 Feb 2022 (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.
This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow.
For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT).
For patients who are MRD "positive" at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD "negative" with AHCT plus teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon completion of induction, patients undergo MRD assessment by next-generation sequencing utilizing ClonoSEQ® (MRD1) and undergo mobilization and collection of autologous hematopoietic progenitor cells for future AHCT. Upon confirmation of adequate hematopoietic cell collection (≥2 x 10^6 CD34+ cells/kg) and result of MRD1 patients will undergo randomization according to the MRD-assigned cohort * MRD negative cohort - Patients will be randomized between arm A and arm B for intensification and maintenance. * MRD positive cohort - Patients will be randomized between arm C and arm D for intensification, consolidation and maintenance.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Dara-VRd intensification, Dara-R maintenance3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance in MRD negative patients |
| Arm B | Active comparator | Drug: AHCT intensification, Dara-R maintenanceAHCT intensification followed by 13 cycles of Dara-R maintenance in MRD negative patients |
| Arm C | Experimental | Drug: AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenanceAHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance in MRD positive patients |
| Arm D | Active comparator | Drug: AHCT intensification, Dara-R consolidation, Dara-R maintenanceAHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance in MRD positive patients |
| Arm M | Other | Drug: Dara-VRd inductionInduction - 6 cycles of Dara-VRd in all participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Age>18 years with no upper age limit
- Newly diagnosed multiple myeloma with indication for initiation of therapy.
- ECOG performance status 0-2
- No prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bortezomib (up to 5.2 mg/m2) and/or cyclophosphamide up to 1000 mg/m2 and/or lenalidomide (up to 21 days of therapy) administered for no longer than 4 weeks prior to enrollment (pre induction). If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be available.
- Measurable disease meeting at least one of the following criteria (at screening or prior to pre induction):
Key exclusion criteria (50 listed)
- Diagnosis of Plasma cell leukemia, primary light chain amyloidosis, POEMS, or Waldenstrom's macroglobulinemia.
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the teclistamab Investigator's Brochure and appropriate package inserts)
- Prior or concurrent exposure to any of the following:
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
- Myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are:
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 |
|---|---|---|
| Dara-VRd intensification, Dara-R maintenanceAlso: darzalex, velcade, revlimid, dexamethasoneEligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort • MRD negative cohort - Patients will be randomized between arm A (3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance) and arm B (AHCT intensification followed by 13 cycles of Dara-R maintenance) for intensification and maintenance | Drug | Arm A |
| AHCT intensification, Dara-R maintenanceAlso: melphalan, darzalex, revlimidEligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort • MRD negative cohort - Patients will be randomized between arm A (3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance) and arm B (AHCT intensification followed by 13 cycles of Dara-R maintenance) for intensification and maintenance | Drug | Arm B |
| AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenanceAlso: melphalan, teclistamab, darzalexEligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort. MRD positive cohort - Patients will be randomized between arm C (AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance) and arm D (AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance) for intensification, consolidation and maintenance. | Drug | Arm C |
| AHCT intensification, Dara-R consolidation, Dara-R maintenanceAlso: melphalan, darzalex, revlimidEligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort. MRD positive cohort - Patients will be randomized between arm C (AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance) and arm D (AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance) for intensification, consolidation and maintenance. | Drug | Arm D |
| Dara-VRd inductionAlso: darzalex, velcade, revlimid, dexamethasonePatients undergo induction therapy with 6 cycles of daratumumab, bortezomib, lenalidomide and dexamethasone | Drug | Arm M |
Primary outcome
Depth of response obtained with 6 cycles of Dara-VRd
Time frame: 6 months
For the primary objective "for all patients" to describe the depth of response obtained with 6 cycles of Dara-VRd and the corresponding endpoint of MRD negativity at end of induction all patients with MRD evaluable
Sustained MRD negativity
Time frame: 18 months
MRD <10-5 assessed before and after 13 cycles of maintenance
3 secondary outcomes
Progression-free survival
Time frame: 60 months
Overall Survival
Time frame: 60 months
Cumulative incidence of MRD resurgence or progression
Time frame: 60 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 22 Sep 2026.
- 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.
Luciano Costa, MD principal investigator
University of Alabama at Birmingham
10 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 Dara-VRd intensification, Dara-R maintenance, AHCT intensification, Dara-R maintenance and AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenance in people with Multiple Myeloma, run by University of Alabama at Birmingham at 10 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 32 inclusion and 50 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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?
Depth of response obtained with 6 cycles of Dara-VRd (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.