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Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma

NCT00784823 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-08-11

Study results available
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Summary

The purpose of this study is to determine the tolerance and potential efficacy of combining dose intense melphalan with escalating doses of bortezomib in patients with multiple myeloma undergoing autologous stem cell transplantation.

Conditions

Interventions

DRUG

Bortezomib 1 mg/m2

* Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line * Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 * Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen

DRUG

Bortezomib 1.3 mg/m2

* Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line * Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 * Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen

DRUG

Bortezomib 1.6 mg/m2

* Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line * Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1 * Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen

DRUG

Melphalan

* Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour * Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration * The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period * Melphalan will be given as a single dose (not split over 2 or more days) * Dosing will be based body surface area calculated using actual body weight

Sponsors & Collaborators

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Scott D Rowley, MD · Director-Blood and Marrow Transplantation Program

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

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 NCT00784823 on ClinicalTrials.gov