Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101 Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse (KIRIMID)

February 27, 2014 updated by: Innate Pharma

Multicenter Phase I Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101, a Human Monoclonal Anti-KIR, Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse

The primary objective of the clinical study is to evaluate, in patients who experience a first or second relapse of their multiple myeloma, the safety of escalating doses of IPH2101 combined with lenalidomide

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber
    • New York
      • New York, New York, United States, 10016
        • NYU Clinical Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • South Carolina
      • Greensville, South Carolina, United States, 29601
        • Saint Francis Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent obtained before any trial-related activities
  2. Progressive disease or relapse of multiple myeloma (according to the IMWG definition) after one or two prior therapeutic treatments or regimens for multiple myeloma that achieved a response duration of at least 6 months
  3. Prior therapeutic treatment regimens may have included Thalidomide and Lenalidomide. Regarding patients previously treated by Lenalidomide, only patients who achieved at least Partial Response duration of at least 6 months can be included. The patient must not have discontinued treatment due to Lenalidomide intolerance.

  4. Measurable disease, as indicated by one or more of the following:

    • Serum M-protein ≥ 0.5 g/dL If Serum Protein Electrophoresis is felt to be unreliable for routine M-protein measurement (particularly for patients with IgA MM), then quantitative immunoglobulin levels can be accepted).
    • Urine Bence-Jones protein ≥ 200 mg/24 h
    • Involved serum Free Light Chains (sFLC) level ≥ 10 mg/dl ( ≥ 100 mg/l) provided sFLC ratio is abnormal (<0.26 or >1.65)
  5. ECOG performance status of 0, 1 or 2

  6. Clinical laboratory values at screening

    • Calculated creatinine clearance (according to MDRD) > 60 ml/min
    • Platelet ≥ 75 x 109 /l for patients with < 50% BM plasma cells, and ≥ 30 x 109 /l for patients with > 50% BM plasma cells
    • ANC > 1 x 109 /l
    • Bilirubin levels < 1.5 ULN ; ALT and AST < 3 ULN (grade 1 NCI)
  7. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing Lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking Lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
  8. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

Exclusion Criteria:

  1. Age < 18 years or > 80 years
  2. Non secreting multiple myeloma or non measurable disease (< 0.5 g /dL M-Protein in serum or < 200 mg urinary M-protein / 24 h or <10 mg/dl involved sFLC)
  3. Life-threatening conditions related or not to MM relapse
  4. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking Lenalidomide)
  5. Known hypersensitivity to thalidomide or IMiD®.
  6. Use of any investigational agent within the last month
  7. Treatment by systemic corticosteroids (except inhaled corticosteroids) or chemotherapy (including consolidation and maintenance) within the last month (use of biphosphonates is permitted)
  8. Radiotherapy within the last month
  9. Primary or associated amyloidosis
  10. Peripheral neuropathy of grade ≥ 3 according to the CTCAE of the NCI

  11. Abnormal cardiac status with any of the following

    • NYHA stage III or IV congestive heart failure
    • myocardial infarction within the previous 6 months
    • cardiac arrhythmia remaining symptomatic despite treatment
  12. Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen
  13. History of or current auto-immune disease
  14. History of other active malignancy within the past 5 years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma)
  15. Serious concurrent uncontrolled medical disorder
  16. History of allograft or solid organ transplantation
  17. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  18. Inability to comply with an antithrombotic regimen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPH2101 and lenalinomide
Drug: IPH2101 combined to lenalidomide

Dose level 1 : 0.2 mg/kg IPH2101(with Lenalidomide 10 mg/day) Dose level 2 : 0.2 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 3 : 1 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 4 : 2 mg/kg IPH2101(with Lenalidomide 25 mg/day)

Extension cohort: 6 patients at the Maximum Tolerated Dose (MTD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with Dose Limiting Toxicity (DLT) at each dose level
Time Frame: 1 year
safety of IPH2101 combined with lenalidomide at different dose levels.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess response rate of the combination
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innate Pharma

Investigators

  • Principal Investigator: Don Benson, MD, The Ohio State University Comprehensive Cancer Center - Columbus OH - USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

February 28, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPH2101-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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