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A Phase I/II Study of Liposomal Doxorubicin (Doxil)/Melphalan/Bortezomib (Velcade) in Relapsed/Refractory Multiple Myeloma

NCT00516191 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2015-03-04

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and tolerability of four dose levels of liposomal doxorubicin, melphalan, and bortezomib in patients with relapsed/refractory MM and to identify a maximum tolerated dose (MTD) of this combination.

Conditions

Interventions

DRUG

Liposomal Doxorubicin/Melphalan/Bortezomib

Day 1 Bortezomib 0.7 mg/m(2)IV + Doxil 10-20 mg/m(2)IV+Melphalan 5-10mg/m(2)IV Day 4 Bortezomib 0.7 mg/m(2)IV Day 8 Bortezomib 0.7 mg/m(2)IV Day 11 Bortezomib 0.7 mg/m(2)IV The treatment cycles will be repeated every 28 days. Dose Level 1: Doxil 10mg/m(2), Melphalan 5 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 2: Doxil 10mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 3: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 0.7mg/m(2) Dose Level 4: Doxil 20mg/m(2), Melphalan 10 mg/m(2), Bortezomib 1.0mg/m(2)

Sponsors & Collaborators

Principal Investigators

  • Thomas G. Martin, M.D. · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2010-10-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00516191 on ClinicalTrials.gov