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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 23, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Busulfan Treatment

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


Participant Flow:   Overall Study
    Busulfan Treatment
STARTED   71 
COMPLETED   57 
NOT COMPLETED   14 
Withdrawal by Subject                1 
Insurance denied participation                11 
ineligible                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Busulfan Treatment

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


Baseline Measures
   Busulfan Treatment 
Overall Participants Analyzed 
[Units: Participants]
 57 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      24  42.1% 
Male      33  57.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      57 100.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   57 


  Outcome Measures

1.  Primary:   Relapse-free Survival   [ Time Frame: at 6 months ]

2.  Primary:   Overall Survival   [ Time Frame: at 6 months ]

3.  Secondary:   Pulmonary Toxicity   [ Time Frame: At 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: sobeckr@ccf.org



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 23, 2017