Phase 2 Study Applying MRD Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by ASCT - TAURUS

Sponsor
Stichting European Myeloma Network
Study ID
NCT06189833
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab will be administered via a subcutaneous injection (SC)
  • Bortezomib — DRUG
    Bortezomib will be administered via a subcutaneous injection (SC)
  • Lenalidomide — DRUG
    Lenalidomide will be administered orally
  • Dexamethasone — DRUG
    Dexamethasone will be administered orally

Study Details

This is a multicenter, single arm, open-label, Phase 2 study in mutiple myeloma with newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan. The study is evaluating a technique called Mass Spectrometry Minimal Residual Disease (MS-MRD) using blood samples and compares it with the minimal residual disease (MRD) technique using bone marrow samples.

Key Dates

Start date
Nov 23, 2023
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: D-VRd + ASCT + DVRD
    Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRD) for 4 induction cycles prior to and 2 consolidation cycles following autologous stem cell transplantation. Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6 Bortezomib SC 1.3mg/m2 on days 1, 8, 15, 22 of cycle 1-6 Lenalidomide orally 25 mg once daily on days 1-21 of cycle 1-6 Dexamethasone 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22 and 23 of cycle 1-6

Primary Outcome Measure

Proportion (%) of agreement and disagreement in the MRD measurements in BM (by NGS-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-consolidation. [ Time Frame: Up to 12 months ]

Central Contacts

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