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

Innate Pharma6 sites in 1 country15 target enrollmentSeptember 2010

ConditionsPatients With Multiple Myeloma Experiencing a First or Second Relapse

InterventionsIPH2101 combined to lenalidomide

Overview

Phase: Phase 1
Intervention: IPH2101 combined to lenalidomide
Conditions: Patients With Multiple Myeloma Experiencing a
Sponsor: Innate Pharma
Enrollment: 15
Locations: 6
Primary Endpoint: number of patients with Dose Limiting Toxicity (DLT) at each dose level
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

February 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Innate Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent obtained before any trial-related activities
•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
•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.
•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)
•ECOG performance status of 0, 1 or 2
•Clinical laboratory values at screening
•Calculated creatinine clearance (according to MDRD) \> 60 ml/min

Exclusion Criteria

•Age \< 18 years or \> 80 years
•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)
•Life-threatening conditions related or not to MM relapse
•Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking Lenalidomide)
•Known hypersensitivity to thalidomide or IMiD®.
•Use of any investigational agent within the last month
•Treatment by systemic corticosteroids (except inhaled corticosteroids) or chemotherapy (including consolidation and maintenance) within the last month (use of biphosphonates is permitted)
•Radiotherapy within the last month
•Primary or associated amyloidosis
•Peripheral neuropathy of grade ≥ 3 according to the CTCAE of the NCI