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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innate Pharma
ClinicalTrials.gov Identifier:
NCT01217203
First received: October 6, 2010
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Patients With Multiple Myeloma Experiencing a
First or Second Relapse
Drug: IPH2101 combined to lenalidomide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Innate Pharma:

Primary Outcome Measures:
  • number of patients with Dose Limiting Toxicity (DLT) at each dose level [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    safety of IPH2101 combined with lenalidomide at different dose levels.


Secondary Outcome Measures:
  • To assess response rate of the combination [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: September 2010
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217203

Locations
United States, Massachusetts
Dana Farber
Boston, Massachusetts, United States, 02115
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
NYU Clinical Cancer Center
New York, New York, United States, 10016
United States, Ohio
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Saint Francis Hospital
Greensville, South Carolina, United States, 29601
Sponsors and Collaborators
Innate Pharma
Investigators
Principal Investigator: Don Benson, MD The Ohio State University Comprehensive Cancer Center - Columbus OH - USA
  More Information

No publications provided

Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT01217203     History of Changes
Other Study ID Numbers: IPH2101-202
Study First Received: October 6, 2010
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 01, 2014