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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Study of Outcomes and Toxicity of Busulfex as Part of a High Dose Chemotherapy Preparative Regimen in Autologous Hematopoietic Stem Cell Transplantation for Patients With Plasma Cell Myeloma

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 Summary:

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.


Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome:

  • Relapse-free Survival [ Time Frame: 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 [ Time Frame: at 6 months ]
    Number of patients alive at the end of the study period


Original Primary Outcome:

  • Relapse-free Survival
  • Overall Survival


Current Secondary Outcome: Pulmonary Toxicity [ Time Frame: 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.


Original Secondary Outcome: Pulmonary Toxicity

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: July 17, 2009
Date Started: June 2009
Date Completion: May 2018
Last Updated: April 13, 2017
Last Verified: April 2017