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

Phase 2

Completed

• Conditions: Multiple Myeloma and Plasma Cell Neoplasm
• Interventions: Drug: busulfan; Drug: cyclophosphamide; Procedure: autologous hematopoietic stem cell transplantation

• Registration Number: NCT00941720
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

Detailed Description

OBJECTIVES:

Primary

* To compare relapse-free survival and overall survival of patients with multiple myeloma treated with IV busulfan vs historical control patients treated with oral busulfan when administered with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem cell transplantation.

Secondary

* To compare pulmonary toxicity rates of IV busulfan vs oral busulfan when administered with cyclophosphamide as a conditioning regimen prior to autologous hematopoietic stem cell transplantation.

OUTLINE: Patients receive high-dose busulfan IV every 6 hours on days -8 to -4 and high-dose cyclophosphamide IV over 4 hours on days -3 and -2. Patients undergo autologous hematopoietic stem cell transplantation on day 0.

After completion of study treatment, patients are followed up periodically.

Study Timeline

• Study Start: 2009-06-11
• Study First Submitted: 2009-07-17
• Study First Submitted QC: 2009-07-17
• Study First Posted: 2009-07-20
• Primary Completion: 2013-02-28
• Study Completion: 2013-02-28
• Results First Submitted: 2014-02-13
• Results First Submitted QC: 2014-02-19
• Results First Posted: 2014-04-02
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Busulfan Treatment	autologous hematopoietic stem cell transplantation	-
Busulfan Treatment	busulfan	-
Busulfan Treatment	cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
Relapse-free Survival	at 6 months	Number of participants without progressive disease at the end of the study period, using the definitions for complete response, partial response and progressive disease from the International Myeloma Working Group .
Overall Survival	at 6 months	Number of patients alive at the end of the study period

Secondary Outcome Measures

Name	Time	Method
Pulmonary Toxicity	At 6 months	Toxicity criteria will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) v3.0. Estimated using exact 95% binomial confidence intervals.

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States