At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Impact of First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade Based Therapy
In Brief
A Phase 2 clinical trial evaluating VELCADE, Lenalidomide, and 4 other interventions for Multiple Myeloma. Completed, enrolled 36 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
25 mg by mouth on days 1-4 of each cycle
20 mg the day before and the day after receiving VELCADE
At least one asprin 81 mg per day. Other option per physician's choice
Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
30 mg/m2 on day 4 of each cycle
40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4