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Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma

NCT00916058 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2019-06-04

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™), in combination with Melphalan in subjects with multiple myeloma who are undergoing an Autologous Stem Cell Transplant.

Conditions

Interventions

DRUG

Bendamustine

30 mg/m\^2 given on day 2 of melphalan

DRUG

Melphalan

100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)

DRUG

Bendamustine

60 mg/m\^2 given on the 2nd day of melphalan

DRUG

Bendamustine

90 mg/m\^2 given on the 2nd day of melphalan

DRUG

Bendamustine

60 mg/m\^2 given on the 1st and 2nd day of melphalan

DRUG

Bendamustine

90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan

DRUG

Bendamustine

125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Tsiporah Shore, M.D. · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-23
Primary Completion
2016-03-11
Completion
2018-03-01

Countries

  • United States

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 NCT00916058 on ClinicalTrials.gov