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Escalating Doses of Thalidomide in Conjunction With Bortezomib and HIgh Dose Melphalan for BSCT

NCT01242267 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-04-02

Study results available
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Summary

The primary objective of this study is to:

• Determine the maximum tolerated dose of thalidomide used in conjunction with dose-intense melphalan, bortezomib and autologous (syngeneic) HSC support in the salvage therapy of patients who failed a prior treatment with dose-intense melphalan

The secondary objectives of this study are to:

* Determine the toxicities resulting from administration of combinations of thalidomide, bortezomib and melphalan
* Determine the complete response (CR) and very good partial response (VgPR) rate in patients undergoing ASCT using thalidomide, bortezomib and melphalan
* Evaluate the treatment-free interval after treatment with the combination of thalidomide, bortezomib and melphalan

Conditions

Interventions

DRUG

Thalidomide+Melphalan +Bortezomib+stem cell transplant

Five days prior to transplant, the patient starts thalidomide. Dose range will be from 600mg for 5 days, to 1000mg for 5 days. Thalidomide dose is increased after groups of 3 to 6 patients have been treated. 4 days before the transplant and again on the day before the transplant the patient will be given bortezomib (VELCADE) intravenously at a dose of 1.6 mg/m2 (mg/m2 means that the dose will be calculated based on the patient's height and weight). 2 days before transplant the patient will be given melphalan 200 mg/m2 intravenously. Dexamethasone is given before the VELCADE and the melphalan.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Scott D Rowley, MD · John Theurer Cancer Center at Hackensack Univ Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-05-11
Primary Completion
2016-01-20
Completion
2016-01-20

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01242267 on ClinicalTrials.gov