OncoMatch/Clinical Trials/NCT05231629
Sequential Therapy in Multiple Myeloma Guided by MRD Assessments
Is NCT05231629 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for multiple myeloma.
Treatment: 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 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-BCMA therapy (teclistamab)
Teclistamab or any anti-BCMA therapy
Cannot have received: anti-CD38 therapy (daratumumab)
Daratumumab or any anti-CD38 therapy
Cannot have received: targeted 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
Cannot have received: investigational vaccine
Investigational vaccine within 4 weeks
Cannot have received: live, attenuated vaccine
Live, attenuated vaccine within 4 weeks before randomization
Cannot have received: radiation therapy
Radiotherapy within 14 days or focal radiation within 7 days
Cannot have received: gene-modified adoptive cell therapy
Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
Cannot have received: cytotoxic chemotherapy
Cytotoxic therapy within 14 days
Cannot have received: proteasome inhibitor
PI therapy within 14 days
Cannot have received: IMiD agent
IMiD agent therapy within 14 days
Lab requirements
Blood counts
Hemoglobin ≥7 g/dL (without prior RBC transfusion within 7 days); Platelets ≥75×10^9/L (<50% plasma cells) or ≥50×10^9/L (≥50% plasma cells, without transfusion support or thrombopoietin receptor agonist within 7 days); ANC ≥1.0×10^9/L (no growth factor support for 7 days for G-CSF/GM-CSF, 14 days for pegylated G-CSF)
Kidney function
eGFR ≥30 mL/min based on MDRD or creatinine clearance measured by 24-hour urine collection
Liver function
AST and ALT ≤2.5×ULN; 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)
Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Colorado Blood Cancer Institute · Denver, Colorado
- Columbia University · New York, New York
- Oregon Health and Science University · Portland, Oregon
- Vanderbilt University · Nashville, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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