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Multiple Myeloma Study: Tailoring Treatment Based on MRD

This study is for people newly diagnosed with multiple myeloma, a type of blood cancer. It's testing different treatment approaches based on how well your cancer responds to initial therapy. All participants will first receive 6 cycles of Dara-VRd (daratumumab, bortezomib, lenalidomide, and dexamethasone). Researchers will then check for minimal residual disease (MRD), which means very few cancer cells remaining. If you become MRD negative, the study will explore if a shorter treatment course can maintain this good response instead of a stem cell transplant. The goal is to see how many patients achieve a very low level of MRD and if that low level can be sustained. You can join if you are over 18 and have not had much prior treatment for multiple myeloma. The study is currently recruiting 300 participants.

Study design
This is an interventional study that will enroll 300 participants. After initial treatment, participants will be randomly assigned to different treatment groups based on their MRD results.
What's involved
You will receive 6 cycles of initial treatment. After this, your MRD will be assessed, and you will continue with further treatment and monitoring based on your MRD results.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the depth of response at 6 months and sustained MRD negativity at 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05231629

Sequential Therapy in Multiple Myeloma Guided by MRD Assessments

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Alabama at Birmingham
~300 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Dara-VRd intensification, Dara-R maintenanceAHCT intensification, Dara-R maintenanceAHCT intensification, Tec-Dara consolidation, Tec-Dara maintenanceAHCT intensification, Dara-R consolidation, Dara-R maintenanceDara-VRd induction

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Depth of response obtained with 6 cycles of Dara-VRd
Measured over 6 months
+1 more outcome measured

Conditions

Multiple Myeloma

Explore related trials

Multiple Myeloma

Where it's being run

10 sites across 9 states
Wisconsin2
Alabama1
Colorado1
New York1
Oregon1
Tennessee1
Texas1
Utah1

Study leadership

  • Luciano Costa, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Luciano Costa, MD
[email protected]
205-934-9695
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test) 3. 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) 4. AST and ALT ≤2.5×ULN 5. eGFR ≥30 mL/min based on Modified Diet in Renal Disease Formula calculation or creatine clearance measured by a 24-hour urine collection 6. 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) 7. Serum calcium corrected for albumin ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L) 7. 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 8. A woman must be

What this trial measures

  • Depth of response obtained with 6 cycles of Dara-VRd6 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 negativity18 months

    MRD \<10-5 assessed before and after 13 cycles of maintenance