Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma

This study has been terminated.
(Due to competing trials, this study is permanenlty closed to patient acrrual.)
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00635024
First received: March 12, 2008
Last updated: August 19, 2011
Last verified: August 2011
Results First Received: August 27, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma and Plasma Cell Neoplasm
Interventions: Biological: anti-thymocyte globulin
Drug: melphalan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One (1) patient was recruited from May 2008 to September 2008 at Mayo Clinic. This trial was permanently closed in March 2009 due to competing trials.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Anti-thymocyte Globulin/Melphalan Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)

Participant Flow:   Overall Study
    Anti-thymocyte Globulin/Melphalan  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Adverse Event                 1  



  Baseline Characteristics
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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
Anti-thymocyte Globulin/Melphalan Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)

Baseline Measures
    Anti-thymocyte Globulin/Melphalan  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  
Prior Stem Cell Transplant  
[units: participants]
 
Yes     1  
No     0  
Parameters of Hematologic Response [1]
[units: participants]
 
Yes     1  
No     0  
Parameters of Hematologic Response [2]
[units: participants]
 
Yes     1  
No     0  
Parameters of Hematologic Response [3]
[units: participants]
 
Yes     1  
No     0  
Parameters of Hematologic Response [4]
[units: participants]
 
Yes     1  
No     0  
[1] Serum M-Spike >=1 g/dL
[2] Serum immunoglobulin free light chain >= 10 mg/dL
[3] Urine M-Spike >= 200 mg/24 hours
[4] Bone marrow plasma cells > 30%



  Outcome Measures
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1.  Primary:   Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response   [ Time Frame: 4 months ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: up to 2 years ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: up to 2 years ]

4.  Secondary:   Duration of Response (DOR)   [ Time Frame: up to 2 years ]

5.  Secondary:   Number of Participants With Severe Non-hematological Adverse Events   [ Time Frame: every month during treatment, up to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
After 1 patient was recruited, this trial temporarily closed to allow the first dose of Anti-thymocyte Globulin to be split over two days. Before the modification was written, it was decided to permanently close this study due to competing trials.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Shaji Kumar
Organization: Mayo Clinic
e-mail: kumar.shaji@mayo.edu


No publications provided


Responsible Party: Shaji K. Kumar, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00635024     History of Changes
Other Study ID Numbers: CDR0000589032, P30CA015083, MC0687, 06-005792
Study First Received: March 12, 2008
Results First Received: August 27, 2010
Last Updated: August 19, 2011
Health Authority: United States: Food and Drug Administration