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Risk Stratification and MRD-driven Maintenance for MM After ASCT

NCT06697483 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Daratumumab

Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance.

DRUG

Lenalidomide

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.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06697483 on ClinicalTrials.gov