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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance.
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.
Fuxing Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGMRD (Minimal Residual Disease) status at 12 months after maintenance
Bone marrow minimal residual disease status at 12 months after maintenance
Time frame: 12 months
CR+VGPR
complete response plus very good partial response at 12 months from maintenance
Time frame: 12 months
Estimated 3 year-PFS
Estimated 3 year progression free survival
Time frame: 3 years
Estimated 3 year OS
Estimated 3 year overall survival
Time frame: 3 years
TRAEs
Treatment related adverse events
Time frame: 3 years
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The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITING