Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma (REMYKIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innate Pharma
ClinicalTrials.gov Identifier:
NCT00999830
First received: October 21, 2009
Last updated: February 23, 2016
Last verified: April 2014
Results First Received: October 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: IPH2101

  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
Patients were recruited in France at the public hospital (10 actives center), from mid of November 2009 to end of October 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients enrolled in the study were analyzed. There was no screen failure during the trial conduct.

Reporting Groups
  Description
Arm A: IPH2101 0.2mg/Kg IPH2101 Fully human anti-KIR monoclonal antibody : 0.2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
Arm B: IPH2101 2mg/kg IPH2101 Fully human anti-KIR monoclonal antibody : 2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.

Participant Flow:   Overall Study
    Arm A: IPH2101 0.2mg/Kg     Arm B: IPH2101 2mg/kg  
STARTED     14     13  
COMPLETED     14     13  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Arm A: IPH2101 0.2mg/Kg every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
Arm B: IPH2101 2mg/kg every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
Total Total of all reporting groups

Baseline Measures
    Arm A: IPH2101 0.2mg/Kg     Arm B: IPH2101 2mg/kg     Total  
Number of Participants  
[units: participants]
  14     13     27  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     12     24  
>=65 years     2     1     3  
Age  
[units: years]
Mean (Standard Deviation)
  58.6  (5.6)     55.9  (10.2)     57.3  (8.1)  
Gender  
[units: participants]
     
Female     3     6     9  
Male     11     7     18  
Region of Enrollment  
[units: participants]
     
France     14     13     27  



  Outcome Measures
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1.  Primary:   Rate of Patients Achieving a Response Based on M-protein or Free Light Chains   [ Time Frame: From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices ]

2.  Secondary:   Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment   [ Time Frame: From the start up to the end of study (15 months) ]

3.  Secondary:   Safety Assessment   [ Time Frame: from screening visit to the End of Study (at each study visit) ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Michel ATTAL
Organization: HOPITAL DE PURPAN Service Hematologie
phone: +33 (0)5.61.77.77.84
e-mail: attal.m@chu-toulouse.fr



Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT00999830     History of Changes
Obsolete Identifiers: NCT01937741
Other Study ID Numbers: IPH2101-201
Study First Received: October 21, 2009
Results First Received: October 15, 2013
Last Updated: February 23, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)