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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Vanderbilt-Ingram Cancer Center

Current Primary Outcome: Number of patients with Minimal Residue Disease (MRD) negativity increase by twenty percent or greater [ Time Frame: 6-months post ASCT ]

Measured by seven-color flow cytometry on previously untreated myeloma patients who receive VLCADE-based chemotherapy


Original Primary Outcome: To show that high dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) significantly increases minimal residual disease (MRD) negativity (as measured by 7 color flow cytometry) from 20% to 40% at 3 months post transplant [ Time Frame: 6-months post ASCT ]

Current Secondary Outcome:

  • Correlate MRD status, pre-and-post transplant [ Time Frame: up to 7 years ]
    pre-and-post transplant with time to relapse
  • Correlate MRD status between induction regimens [ Time Frame: 6 months post ASCT ]
    regimens for correlation are VRD (VELCADE, lenalidomide, dexamethasone) and VDD (VELCADE, liposomal doxorubicin, dexamethasone)


Original Secondary Outcome:

  • To correlate minimal residual disease (MRD) status pre and post transplant with time to relapse [ Time Frame: 7 years ]
  • To correlate minimal residual disease (MRD) status pre‐transplant among the 2 induction regimens‐VRD (VELCADE, lenalidomide, dexamethasone) and VDD (VELCADE, liposomal doxorubicin, dexamethasone) [ Time Frame: 6 months post ASCT ]


Information By: Vanderbilt-Ingram Cancer Center

Dates:
Date Received: October 4, 2010
Date Started: November 2010
Date Completion: February 2017
Last Updated: August 10, 2016
Last Verified: August 2016