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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:
ClinicalTrials.gov Identifier:
NCT00635024
First Posted: March 13, 2008
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
Results First Submitted: August 27, 2010  
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: 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 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1 100.0% 
>=65 years      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
 
Female      1 100.0% 
Male      0   0.0% 
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 
[1] Serum M-Spike >=1 g/dL
Parameters of Hematologic Response [1] 
[Units: Participants]
 
Yes   1 
No   0 
[1] Serum immunoglobulin free light chain >= 10 mg/dL
Parameters of Hematologic Response [1] 
[Units: Participants]
 
Yes   1 
No   0 
[1] Urine M-Spike >= 200 mg/24 hours
Parameters of Hematologic Response [1] 
[Units: Participants]
 
Yes   1 
No   0 
[1] Bone marrow plasma cells > 30%


  Outcome Measures
  Show All Outcome Measures

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



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00635024     History of Changes
Other Study ID Numbers: CDR0000589032
P30CA015083 ( U.S. NIH Grant/Contract )
MC0687 ( Other Identifier: Mayo Clinic Cancer Center )
06-005792 ( Other Identifier: Mayo Clinic IRB )
First Submitted: March 12, 2008
First Posted: March 13, 2008
Results First Submitted: August 27, 2010
Results First Posted: October 18, 2010
Last Update Posted: February 10, 2017