Multiple Myeloma
Conditions
Keywords
R2-ISS stage, Minimal Residual Disease, Lenalidomide, Daratumumab
Brief 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.
Interventions
DRUGDaratumumab
Patients who are R2-ISS 3 or 4 OR MRD (Minimal Residual Disease) positivity will receive daratumumab plus lenalidomide maintenance.
DRUGLenalidomide
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
Peking University People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT. 2. Must have a partial response (PR) or better response before maintenance. 3. Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2. 4. This study allows for post-ASCT consolidation therapy. 5. ANC ≥ 1.0 x 10\^9/L, Hb ≥ 85 g/L PLT ≥ 75 x 10\^9/L (if BMPC \< 50%) or PLT ≥ 50 x 10\^9/L (if BMPC ≥ 50%). 6. No active infection. 7. a).TBIL\<1.5 x upper limit of normal (ULN) (\<3 x ULN in patients with Gilbert's syndrome); b).AST and ALT \<3 x ULN.; c. Creatinine clearance ≥ 45mL/min.
Exclusion criteria
1. Must not refractory or non-tolerate to lenalidomide in Arm A. 2. Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B. 3. Must not have progressed on multiple myeloma (MM) therapy before screening 4. Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal； 5. Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification 6. History of stroke or serious thrombotic event within 12 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRD (Minimal Residual Disease) status at 12 months after maintenance | 12 months | Bone marrow minimal residual disease status at 12 months after maintenance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CR+VGPR | 12 months | complete response plus very good partial response at 12 months from maintenance |
| Estimated 3 year-PFS | 3 years | Estimated 3 year progression free survival |
| Estimated 3 year OS | 3 years | Estimated 3 year overall survival |
| TRAEs | 3 years | Treatment related adverse events |
Countries
China
Contacts
Primary ContactYang Dr, M.D.
Outcome results
None listed