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Busulfan, Cyclophosphamide, and Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma

NCT00941720 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2020-07-24

Study results available
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Summary

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide followed by an autologous stem cell transplant works in treating patients with multiple myeloma.

Conditions

  • Multiple Myeloma and Plasma Cell Neoplasm

Interventions

DRUG

busulfan

IV busulfan 0.8 mg/kg every 6 hours x 16 doses

DRUG

cyclophosphamide

IV cyclophosphamide 60 mg/kg over 4 hours x 2 days

PROCEDURE

autologous hematopoietic stem cell transplantation

infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Ronald M. Sobecks, MD · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-11
Primary Completion
2013-02-28
Completion
2013-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00941720 on ClinicalTrials.gov