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

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ClinicalTrials.gov Identifier: NCT00941720
Recruitment Status : Active, not recruiting
First Posted : July 20, 2009
Results First Posted : April 2, 2014
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Drug: busulfan
Drug: cyclophosphamide
Procedure: autologous hematopoietic stem cell transplantation
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Busulfan Treatment
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 71
Completed 57
Not Completed 14
Reason Not Completed
Withdrawal by Subject             1
Insurance denied participation             11
ineligible             2
Arm/Group Title Busulfan Treatment
Hide Arm/Group Description

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

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

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

Overall Number of Baseline Participants 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants
58  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
Female
24
  42.1%
Male
33
  57.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
9
  15.8%
White
47
  82.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
57
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 57 participants
57
1.Primary Outcome
Title Relapse-free Survival
Hide Description 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 .
Time Frame at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Busulfan Treatment
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
48
2.Primary Outcome
Title Overall Survival
Hide Description Number of patients alive at the end of the study period
Time Frame at 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Busulfan Treatment
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
53
3.Secondary Outcome
Title Pulmonary Toxicity
Hide Description 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.
Time Frame At 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Busulfan Treatment
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.5
(0.4 to 12.1)
Time Frame 100 days after off treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Busulfan Treatment
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Busulfan Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Busulfan Treatment
Affected / at Risk (%) # Events
Total   12/57 (21.05%)    
Blood and lymphatic system disorders   
Blood and lymphatic system disorders - other (Relapsed disease) * 1  1/57 (1.75%)  2
General disorders   
Death NOS * 1  5/57 (8.77%)  5
Immune system disorders   
Allergic reaction - Angioedemia due to ACE Inhibitors * 1  1/57 (1.75%)  1
Infections and infestations   
Lung Infection * 1  1/57 (1.75%)  1
Injury, poisoning and procedural complications   
Injury, poisoning and procedural complications - Other (patient fell and hit head. Never recovered) * 1  1/57 (1.75%)  2
Respiratory, thoracic and mediastinal disorders   
Adult Respiratory Distress Syndrome * 1  1/57 (1.75%)  1
Dyspenia * 1  1/57 (1.75%)  1
Laryngeal edema * 1  1/57 (1.75%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Busulfan Treatment
Affected / at Risk (%) # Events
Total   5/57 (8.77%)    
Gastrointestinal disorders   
Colitis - diverticulitis * 1  1/57 (1.75%)  1
Gastrointestinal disorders - Clostridium difficile in urine and diarrhea * 1  1/57 (1.75%)  1
General disorders   
Fever * 1  1/57 (1.75%)  3
Infections and infestations   
Catheter related infection * 1  1/57 (1.75%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspenia * 1  1/57 (1.75%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ronald Sobecks
Organization: CCCC
Phone: 216-444-6833
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00941720     History of Changes
Other Study ID Numbers: CASE1A07
P30CA043703 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2009
First Posted: July 20, 2009
Results First Submitted: February 13, 2014
Results First Posted: April 2, 2014
Last Update Posted: May 31, 2018