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Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients

NCT00469209 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-09-24

Study results available
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Summary

Primary Objectives:

1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
2. To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
3. To determine the effects of bortezomib on melphalan pharmacokinetics

Conditions

Interventions

DRUG

Trisenox (Arsenic Trioxide)

0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).

DRUG

Velcade (Bortezomib)

Arm 1 (Level 1): 1.0 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute). Arm 2 (Level 2): 1.5 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).

DRUG

Melphalan

100 mg/m2 by vein days -4,-3, over 30 minutes

DRUG

Vitamin C (Ascorbic Acid)

1000 mg once a day through the vein for 7 days.

Sponsors & Collaborators

  • Cephalon

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Muzaffar H. Qazilbash, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-12-31
Completion
2008-12-31

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 NCT00469209 on ClinicalTrials.gov