NCT01215344

First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade

Impact of First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade Based Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

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

Timeline

• Start date: 2010-11-01
• Primary completion: 2015-11-01
• Completion: 2018-03-01
• First posted: 2010-10-06
• Last updated: 2018-05-15
• Results posted: 2017-06-28

Locations

2 sites across 1 country: United States