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A Phase I/II Trial of Romidepsin (Depsipeptide) and Bortezomib in Patients With Relapsed Myeloma

NCT00431990 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-08-12

No results posted yet for this study

Summary

The purpose of the first phase of the study is to determine whether, and at what dose, depsipeptide, bortezomib and dexamethasone can be safely administered to patients with Multiple Myeloma. The second phase of the study will establish whether depsipeptide, bortezomib and dexamethasone is effective in the treatment of patients with multiple myeloma. The study will also examine the role of maintenance therapy with depsipeptide.

Conditions

Interventions

DRUG

depsipeptide

Cohort 1. Dose escalation, IV, Weeklyx3 in a 4week cycle. Cohort 2A. 12mg/m2, IV, Weeklyx3 in a 4week cycle. Cohort 2B. 12mg/m2, IV, Weeklyx2 in a 3week cycle.

DRUG

bortezomib

Cohort 1 and 2A. 3.5mg/m2, IV, day 1, 4, 8, 11 in 28 day cycle. Cohort 2B. 3.5mg/m2, IV, day 1, 4, 8, 11 in 21 day cycle

DRUG

dexamethasone

20mg for 2 days with each dose of bortezomib

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Simon J Harrison, MBBS, PhD. · Peter MacCallum Cancer Centre, Australia

  • Miles Prince, MD · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2011-12-31
Completion
2012-01-31

Countries

  • Australia

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 NCT00431990 on ClinicalTrials.gov