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Bispecific Antibody Therapy vs Autologous Stem Cell Transplantation as Consolidation for Newly Diagnosed, Standard Risk Multiple Myeloma
Sponsor study identifier
interventional
920
0 countries
N/A
Study Start
December 23, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
August 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2053
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This phase II/III trial compares the usual treatment (daratumumab and hyaluronidase, lenalidomide, bortezomib and dexamethasone \[DaraRVd\] regimen followed by autologous stem cell transplant \[ASCT\] followed by maintenance therapy) to DaraRVd treatment followed by bispecific antibody therapy (teclistamab and/or talquetamab) followed by maintenance therapy in treating patients with newly diagnosed, standard risk multiple myeloma. Daratumumab is in a class of medications called monoclonal antibodies. Daratumumab and hyaluronidase works by helping the body to slow or stop the growth of cancer cells. Hyaluronidase is an endoglycosidase. It helps to keep daratumumab in the body longer so that the medication will have a greater effect. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. Bortezomib blocks several molecular pathways in a cell and may cause cancer cells to die. It is a type of proteasome inhibitor and a type of dipeptidyl boronic acid. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Teclistamab and talquetamab are bispecific monoclonal antibodies that can bind to targets on both cancer cells and immune cells (T-cells) that may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving DaraRVd followed by teclistamab and/or talquetamab may work better in increasing the likelihood of reducing the cancer burden to the point that it is undetectable, and prolonging the time until the cancer returns compared to DaraRVd followed by ASCT.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2053
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2026
Actual (reported)October 22, 2026
Actual (reported)December 23, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2053
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Proportion of patients who are classified as being MRD-negative post-consolidation (Phase II)
Will be defined as the number of patients who are identified as having no detectable minimal residual disease (MRD) (absence of malignant cells at a sensitivity threshold of 10\^-5 or lower using next generation sequencing) after consolidation therapy divided by the total number of evaluable patients on the given treatment arm. Will conduct separate pairwise comparisons of each of the three bispecific antibody (BsAb) treatment arms against the common control arm.
Up to 1 year from registration
Progression-free survival (PFS) (Phase III)
Will be evaluated and compared using a log-rank test to compare differences between those randomized to receive the most promising BsAb as consolidation (identified from the phase II portion of this trial) vs. those randomized to receive consolidation with high-dose melphalan/autologous stem cell transplant (ASCT). PFS distributions will be evaluated graphically using the methods of Kaplan and Meier, 4-year PFS rates with corresponding 95% confidence intervals will be estimated.
From date of randomization to the date of documented disease progression and/or death due to any cause, whichever comes first, assessed up to 20 years
Overall survival (OS) (Phase II)
From randomization to the time of death due to any cause, assessed up to 20 years
ate of conversion from MRD-positive to MRD-negative post-induction to post-consolidation in each treatment arm (Phase II)
Up to 12 months from randomization
Overall rate of MRD-negativity in each treatment arm (Phase II)
Up to 3 years from randomization
Rate of MRD-negativity after 2 years of maintenance in each treatment arm (Phase II)
Up to 3 years from randomization
Rate of grade 3+ adverse events in each treatment arm (Phase II)
Up to 3 years from randomization
PFS by sex
Up to 20 years
PFS by race
Up to 20 years
PFS by ethnicity
Up to 20 years
INDUCTION: Patients receive the DaraRVd regimen consisting of: 1) daratumumab and recombinant human hyaluronidase SC on days 1, 8, and 15 of each cycle; 2) lenalidomide PO on days 1-14 of each cycle; 3) bortezomib SC on days 1, 4, 8, and 11 of each cycle; and 4) dexamethasone PO or IV on days 1, 4, 8, 11, and 15 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients undergo ASCT and receive melphalan IV on a single day or on two consecutive days. MAINTENANCE: Patients receive daratumumab and recombinant human hyaluronidase SC on day 1 of each cycle and lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days for 26 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT, collection of blood, and bone marrow aspiration/biopsy throughout the study. Patients may also undergo MRI on study.
Given SC
Sarah Holstein, MD, PhD
Alliance for Clinical Trials in Oncology
Hira Shaikh, MBBS
Alliance for Clinical Trials in Oncology
First Submitted
October 15, 2026
First Posted
October 22, 2026
Study Start
December 23, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
August 1, 2033
EstimatedINDUCTION: Patients receive the DaraRVd regimen as in Phase II Arm 1. CONSOLIDATION: Patients receive teclistamab SC on days 1, 4, 8, and 15 of cycle 1 and then on days 1 and 15 of cycles thereafter. Cycles repeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive daratumumab and recombinant human hyaluronidase and lenalidomide as in Phase II Arm 1. Patients also undergo PET/CT, collection of blood, and bone marrow aspiration/biopsy throughout the study. Patients may also undergo MRI on study.
INDUCTION: Patients receive the DaraRVd regimen as in Phase II Arm 1. CONSOLIDATION: Patients receive talquetamab SC on days 1, 4, 8, and 15 of cycle 1 and then on days 1 and 15 of cycles thereafter. Cycles repeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive daratumumab and recombinant human hyaluronidase and lenalidomide as in Phase II Arm 1. Patients also undergo PET/CT, collection of blood, and bone marrow aspiration/biopsy throughout the study. Patients may also undergo MRI on study.
INDUCTION: Patients receive the DaraRVd regimen as in Phase II Arm 1. CONSOLIDATION: Patients receive teclistamab SC and talquetamab SC on days 1, 4, 8, and 15 of cycle 1 and then on days 1 and 15 of cycles thereafter. Cycles repeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive daratumumab and recombinant human hyaluronidase and lenalidomide as in Phase II Arm 1. Patients also undergo PET/CT, collection of blood, and bone marrow aspiration/biopsy throughout the study. Patients may also undergo MRI on study.
INDUCTION: Patients receive the DaraRVd regimen as in Phase II Arm 1. CONSOLIDATION: Patients undergo ASCT and receive melphalan as in Phase II Arm 1. MAINTENANCE: Patients receive daratumumab and recombinant human hyaluronidase and lenalidomide as in Phase II Arm 1. Patients also undergo PET/CT, collection of blood, and bone marrow aspiration/biopsy throughout the study. Patients may also undergo MRI on study.
INDUCTION: Patients receive the DaraRVd regimen as in Phase II Arm 1. CONSOLIDATION: Patients receive teclistamab alone as in Phase II Arm 2, talquetamab alone as in Phase II Arm 3, or teclistamab and talquetamab together as in Phase II Arm 4. MAINTENANCE: Patients receive daratumumab and recombinant human hyaluronidase and lenalidomide as in Phase II Arm 1. Patients also undergo PET/CT, collection of blood, and bone marrow aspiration/biopsy throughout the study. Patients may also undergo MRI on study.
Given PO
Undergo collection of blood
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Undergo MRI
Given SC
Given PO or IV
Undergo ASCT
Given IV
Given SC
Given SC
Undergo PET
Undergo CT
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2053
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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