A Study Evaluating the Activity, Safety and Pharmacology of Two Doses of IPH2101, a Human Monoclonal Anti-KIR Antibody, in Patients With Multiple Myeloma in Stable Partial Response After a First Line Therapy (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: August 8, 2013
Last verified: August 2013
  Purpose

Development of new treatments for diseases such as multiple myeloma is a focus for research. The research being conducted is on treatment called Anti-KIR, which activates the body's own cells to kill tumor cells. This is different from many other treatments where chemicals are given to kill tumor cells.The primary objective of the study is to evaluate the clinical activity of two different dose regimens (0.2 mg/kg, leading to an intermittent saturation of NK receptors and 2mg/kg leading to a sustained saturation of NK receptors) of IPH2101 administered as a single agent in multiple myeloma patients who achieved, after the completion of any first line treatment, including conventional or high dose chemotherapies, a stable partial or very good partial response (PR or VGPR).


Condition Intervention Phase
Multiple Myeloma
Drug: IPH2101 Fully human anti-KIR monoclonal antibody
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Phase II Study Evaluating the Anti-tumour Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Human Monoclonal Anti-KIR Antibody, in Patients With Multiple Myeloma in Stable Partial Response After a First Line Therapy

Resource links provided by NLM:


Further study details as provided by Innate Pharma:

Primary Outcome Measures:
  • M-protein will be measured in serum at Screening and every 4 weeks during the study period from Cycle1-day1 to End of Study [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess pharmacokinetic (PK) parameters of Anti-KIR [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
  • To assess pharmacodynamic parameters of Anti-KIR [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
  • To assess Safety of 2 dose regimens of Anti-Kir [ Time Frame: every 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: September 2009
Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPH 2101 0.2 mg/kg Drug: IPH2101 Fully human anti-KIR monoclonal antibody
One infusion of IPH2101 every 4 weeks
Experimental: IPH2101 2.0 mg/kg Drug: IPH2101 Fully human anti-KIR monoclonal antibody
One infusion of IPH2101 every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. MM which initially required a systemic therapy and received a first line treatment, conventional doses of chemotherapies or high dose chemotherapy and an autologous transplantation of hematopoietic cells, followed or not by a consolidation treatment.
  2. Residual disease considered as evaluable with:

    • Quantifiable serum M-protein: ≥ 3 g/l, except for spike in the beta globulin area. In this particular case serum M-protein is considered quantifiable if ≥ 10g/l
    • If serum M-protein is < 3g/l, measurable involved Free Light Chains ≥ 100 mg/l and an abnormal Free Light chains ratio (<0.26 or > 1.65)
  3. Responses which are partial (PR and VGPR) and in plateau

    • Partial response should meet the IMWG uniform response criteria: a ≥ 50% reduction from value of serum M-protein before the first line chemotherapy treatment and a reduction in 24h urinary M-protein by ≥ 90% or to < 200 mg /24h;
    • Very good partial response according to the IMWG uniform response criteria with 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg/24h; furthermore the M-protein should spike in the gamma globulin area;
    • Plateau phase is defined by :

      • For patients with serum M-protein ≥ 3g/l: stable levels of M-protein in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. Fluctuations of ± 25 % and ± 2 g/l in Serum M-protein levels are allowed.
      • For Patients with serum M-protein < 3g/l: stable levels Free Light Chains in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. Fluctuations of ± 25 % of involved serum Free Light Chain are allowed.
  4. ECOG performance status of 0, 1 or 2.
  5. Clinical laboratory values at screening:

    • Calculated creatinine clearance (according to MDRD) > 50 ml/min
    • Platelet > 50 x 109 /l
    • ANC > 1 x 109 /l
    • Bilirubin levels < 1.5 ULN; ALT and AST < 2.5 ULN
  6. Male or female patient who accepts and is able to use recognised effective contraception (oral contraceptives, IUCD, barrier method of contraception in conjunction with spermicidal jelly) throughout the study.
  7. Signed inform consent obtained before any trial-related activities

Exclusion Criteria:

  1. Age < 18 years old or > 75 years old
  2. Previous consolidation/ maintenance therapy by Imid (thalidomide, lenalidomid) or bortezomib within the last 2 months
  3. Treatment with chemotherapy, systemic corticosteroid within the previous 2 months
  4. Treatment with growth factors (EPO, G- or GM-CSF) within the previous 1 month
  5. Radiotherapy for bone or visceral lesion within the last 3 months
  6. Use of any investigational agent within the last 2 months
  7. Primary or associated amyloidosis
  8. Peripheral neuropathy of grade ≥ III according to the CTCAE of the NCI
  9. Abnormal cardiac status with any of the following

    1. NYHA stage III or IV congestive heart failure
    2. myocardial infarction within the previous 6 months
    3. symptomatic cardiac arrhythmia despite treatment
  10. Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen
  11. History of or current auto-immune disease
  12. Serious concurrent uncontrolled medical disorder
  13. History of other malignancy for less then 5 years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma)
  14. History of allogenic hematopoietic cell or solid organ transplantation
  15. Pregnant or lactating women
  16. Any medical condition which is regarded by the investigator as incompatible with the study participation
  17. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  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: NCT00999830

Locations
France
C.H.R.U. de Caen - Hôpital Bretonneau
Caen, France, 14033
CHU Dijon
Dijon, France, 21079
CHRU Lille
Lille, France, 59037
Hôpital Dupuytren
Limoges, France, 87042
Institut Paoli Calmettes
Marseille, France, 13273
CHU Nancy
Nancy, France, 54511
CHRU Nantes
Nantes, France, 44093
Hôpital Saint Antoine
Paris, France, 75012
Hopital Saint Louis
Paris, France, 75010
Hopital Purpan
Toulouse, France, 31059
C.H.R.U. de Tours
Tours, France, 37044
Sponsors and Collaborators
Innate Pharma
Investigators
Principal Investigator: Michel ATTAL, MD CHU Toulouse
  More Information

No publications provided

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
Last Updated: August 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014