Conditions: Multiple Myeloma
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief summary:
The purpose of this study is to study the MRD status after VELCADE based induction therapy (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on MRD status post-transplant. Our hypothesis is that MRD-status will continue to increase significantly at 3 months post-transplant and will validate that HDC and ASCT needs to be performed even when patients have achieved major response after induction therapy with novel agents.

Detailed description:

Arms:
arm 1: VELCADE, Lenalidomide, Dexamethasone arm 2: VELCADE, liposomal doxorubicin, dexamethasone

Interventions: intervention 1: VELCADE intervention 2: Lenalidomide intervention 3: Dexamethasone intervention 4: DVT prophylaxis intervention 5: Bisphosphonates intervention 6: Liposomal doxorubicin intervention 7: Dexamethasone
Intervention descriptions: intervention 1: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle intervention 2: 25 mg by mouth on days 1-4 of each cycle intervention 3: 20 mg the day before and the day after receiving VELCADE intervention 4: At least one asprin 81 mg per day. Other option per physician's choice intervention 5: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care. intervention 6: 30 mg/m2 on day 4 of each cycle intervention 7: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4

Protocol document: