Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients With Multiple Myeloma

NCT01605032 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-08-20

Study results available
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Summary

This phase II trial studies how well busulfan, melphalan, and bortezomib before first-line stem cell transplant works in treating patients with multiple myeloma. Giving chemotherapy before a peripheral blood stem cell transplant may stop the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Conditions

  • DS Stage I Plasma Cell Myeloma
  • DS Stage II Plasma Cell Myeloma
  • DS Stage III Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma

Interventions

DRUG

Busulfan

Given IV

DRUG

Melphalan

Given IV

DRUG

Bortezomib

Given IV

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous PBSCT

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo autologous PBSCT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Ira Braunschweig · Albert Einstein College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

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Entities

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 NCT01605032 on ClinicalTrials.gov