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Trial record 44 of 2571 for:    "Plasma Cell Neoplasm"

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

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.
 
ClinicalTrials.gov Identifier: NCT00635024
Recruitment Status : Terminated (Due to competing trials, this study is permanenlty closed to patient acrrual.)
First Posted : March 13, 2008
Results First Posted : October 18, 2010
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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
Enrollment 1
Recruitment Details 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  
Arm/Group Title Anti-thymocyte Globulin/Melphalan
Hide Arm/Group Description Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Anti-thymocyte Globulin/Melphalan
Hide Arm/Group Description Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
Prior Stem Cell Transplant  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants
Yes 1
No 0
Parameters of Hematologic Response   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants
Yes 1
No 0
[1]
Measure Description: Serum M-Spike >=1 g/dL
Parameters of Hematologic Response   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants
Yes 1
No 0
[1]
Measure Description: Serum immunoglobulin free light chain >= 10 mg/dL
Parameters of Hematologic Response   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants
Yes 1
No 0
[1]
Measure Description: Urine M-Spike >= 200 mg/24 hours
Parameters of Hematologic Response   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants
Yes 1
No 0
[1]
Measure Description: Bone marrow plasma cells > 30%
1.Primary Outcome
Title Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response
Hide Description

Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.

Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.

Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours.

Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels.

Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant was evaluable for the primary endpoint.
Arm/Group Title Anti-thymocyte Globulin/Melphalan
Hide Arm/Group Description:
Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from registration to death of any cause.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-thymocyte Globulin/Melphalan
Hide Arm/Group Description:
Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
Overall Number of Participants Analyzed 1
Median (95% Confidence Interval)
Unit of Measure: months
2.9
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description

PFS was defined as the time from registration to progression or death due to any cause.

Progression was defined as any one or more of the following:

An increase of 25% from lowest confirmed response in:

  • Serum M-component (absolute increase >= 0.5g/dl)
  • Urine M-component (absolute increase >= 200mg/24hour
  • Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
  • Bone marrow plasma cell percentage (absolute increase of >=10%)
  • Definite development of new bone lesion or soft tissue plasmacytomas
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-thymocyte Globulin/Melphalan
Hide Arm/Group Description:
Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
Overall Number of Participants Analyzed 1
Median (95% Confidence Interval)
Unit of Measure: months
2.9
4.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was calculated from the documentation of response (CR, VGPR or PR) until the date of progression in the subset of patients who responded.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients are non-evaluable - no patients responded to treatment.
Arm/Group Title Anti-thymocyte Globulin/Melphalan
Hide Arm/Group Description:
Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Severe Non-hematological Adverse Events
Hide Description Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0)
Time Frame every month during treatment, up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-thymocyte Globulin/Melphalan
Hide Arm/Group Description:
Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
Yes 1
No 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anti-thymocyte Globulin/Melphalan
Hide Arm/Group Description Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
All-Cause Mortality
Anti-thymocyte Globulin/Melphalan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Anti-thymocyte Globulin/Melphalan
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anti-thymocyte Globulin/Melphalan
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  1/1 (100.00%)  1
Immune system disorders   
Hypersensitivity  1  1/1 (100.00%)  1
Infections and infestations   
Opportunistic Infection  1  1/1 (100.00%)  1
Investigations   
Leukopenia  1  1/1 (100.00%)  1
Neutrophil Count Decreased  1  1/1 (100.00%)  1
Platelet Count Decreased  1  1/1 (100.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Shaji Kumar
Organization: Mayo Clinic
EMail: kumar.shaji@mayo.edu
Layout table for additonal information
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