Multiple myeloma
Conditions
Interventions
Phase 1 trial group:Bortezomib, doxorubicin, and dexamethasone (VAd) regimen induction chemotherapy for 2 cycles
Phase 2 trial group:daratumumab combined with bortezomib, lenalidomide, dexamethasone, and doxorubicin (Dara-VRdA) followed by autologous hematopoietic stem cell transplantation (ASCT)
Sponsors
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age =70 years old (including 70 years old), diagnosed with multiple myeloma according to IMWG criteria. 2) ECOG performance score 0-2. 3) Disease is measurable: serum M-protein =10 g/L or = 5 g/L in patients with IgA, IgD, IgE or IgM multiple myeloma; Urinary M-protein level =200 mg/24 hours; For those whose Serum or Urine M-protein does not meet the measurable criteria but the light chain type, serum free light chain(sFLC): involved sFLC level = (100 mg/L) provided serum FLC ratio is abnormal. 4) At least one high-risk cytogenetic factor [del(17p), t(4;14), t(14;16), t(14;20)] should be identified prior to the third cycle of induction therapy. The subjects received VAd for first two cycles of induction chemotherapy, regardless of cytogenetic factors. 5)c have adequate organ function: Blood routine: absolute neutrophil count=1.0×10^9/L, platelet count =50×10^9/L; Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5×upper limit of normal (ULN); total serum bilirubin = 1.5×ULN; Echocardiography: left ventricular ejection fraction (LVEF)>50%. 6) Women of reproductive age must consent to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the end of the study; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men must consent to use contraceptive measures during the study period and within 3 months after the end of the study period. 7) Subject must sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Age > 71 years old or 470ms. 10) Active infection, including but not limited to HAV, HBV, HCV, HIV. 11) Grade 2 or above peripheral neuropathy or neuralgia (CTCAE 5.0 standard). 12) The investigator believes that the patient has other conditions that are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD negative rate after completion of consolidation therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| sCR ratio after consolidation therapy;Objective response rate,ORR;Progression-free Survival, PFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactJianqing Mi
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed