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

NCT01215344 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-05-15

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Madan Jagasia, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-11-30
Completion
2018-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01215344 on ClinicalTrials.gov