Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma

NCT ID: NCT01222286

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-01-31

Brief Summary

The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma.

Detailed Description

This is a randomized Phase II, open label, multi-centre study, with two independent arms.

Patients receive 6 injections of IPH2101, at the dose of 0.2 mg/kg or 2 mg/kg (according to their randomization) administered over one hour infusion at four weeks intervals.

A patient whose disease achieves at least a minimal response to study treatment at any time during the initial period of 6 cycles can be treated with an additional period of treatment of 6 cycles.

Patients are followed 6 months after treatment completion or until a KIR occupancy level < 30% (i.e if the time required for KIR desaturation was > 6 months), whichever is longer.

Conditions

Smoldering Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IPH2101 0.2 mg/kg

0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

Group Type: EXPERIMENTAL

IPH2101

Intervention Type: DRUG

0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

IPH2101 2 mg/kg

2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

Group Type: EXPERIMENTAL

IPH2101

Intervention Type: DRUG

0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

Interventions

IPH2101

0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

Intervention Type: DRUG

Other Intervention Names

a human monoclonal anti-KIR antibody (1-7F9)

Eligibility Criteria

Inclusion Criteria

1. SMM of any risk level according to a definition derived of the International Myeloma Working Group definition ( Br J Haematol 2003; 121: 749) : Serum M protein ≥ 3 g/dl , AND/OR Bone Marrow plasma cells ≥ 10 % with no evidence of end-organ damage (CRAB)

• (C)Absence of hypercalcemia : Ca < 10.5 mg/dl
• (R)Absence of renal failure : creatinine < 2mg/dl (177 μmol/l) or calculated creatinine clearance(according to MDRD) > 50 ml/min
• (A)Absence of anemia : Hb > 11 g/dl
• (B)Absence of lytic bone lesion on standard skeletal survey (MRI could be used if clinically indicated)

2. Measurable disease defined as a disease with a serum M protein ≥ 1 g/dl

3. No evidence of fatigue, recurrent infections or any clinical suspicion of MM

4. Diagnosis of SMM confirmed on two consecutive assessments (ie fluctuation under 25% of serum protein level) performed with at least a 4 week interval.

5. Age > 18 years or < 75 years

6. ECOG performance status of 0 or 1

7. 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 when relevant

8. Informed consent signed by the patient

Exclusion Criteria

1. Previous treatment having a proven or potential impact on myelomatous cells proliferation or survival (including IMiDs or proteasome inhibitors, conventional chemotherapies within the last 5 years, steroids within the last month prior to enrolment). Previous bisphosphonates started less than 3 months prior to enrolment.

2. Use of any investigational agent within the last 3 months

3. Clinical laboratory values at screening

• Platelet < 75 x 10^9 /l
• ANC < 1.5 x 10^9 /l
• Bilirubin levels >1.5 ULN ; ALT and AST > 3 ULN (grade 1 NCI)

4. Primary or associated amyloidosis

5. 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 requiring treatment or persisting despite appropriate treatment

6. Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen

7. History of or current auto-immune disease

8. History of other active malignancy within the past five years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma).

9. Serious concurrent uncontrolled medical disorder

10. History of allograft or solid organ transplantation

11. Pregnant or lactating women

12. Any condition potentially hampering compliance with the study protocol and follow-up schedule

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innate Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikhil Munshi, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute- Medical Oncology- Boston MA-USA

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mount Sinai School of Medicine

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

IPH2101-203

Identifier Type: -

Identifier Source: org_study_id

NCT01960959

Identifier Type: -

Identifier Source: nct_alias