Risk Stratification and MRD-driven Maintenance for MM After ASCT

Sponsor
Peking University People's Hospital
Study ID
NCT06697483
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance.
  • Lenalidomide — DRUG
    Patients are R2-ISS 1,2 and MRD (Minimal Residual Disease) negative after autologous stem cell transplantation. Patients will receive the single drug lenalidomide maintenance.

Study Details

This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation. This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.

Key Dates

Start date
Dec 1, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Lenalidomide
    For patients with low-risk or intermediate-low risk and minimal residual disease negativity before maintenance
  • Other: Daratumumab and Lenalidomide
    For patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance

Primary Outcome Measure

MRD (Minimal Residual Disease) status at 12 months after maintenance [ Time Frame: 12 months ]

Central Contacts

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