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

Sponsor:	Innate Pharma
Information provided by (Responsible Party):	Innate Pharma
ClinicalTrials.gov Identifier:	NCT01222286

Purpose

This is a randomized Phase II, open label, multi-centre study evaluating 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. Patients will receive 6 injections of IPH2101, at the dose of 0.2 mg/kg or 2 mg/kg (according to their randomization). Patients will be 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.

Condition	Intervention	Phase
Smoldering Multiple Myeloma	Drug: IPH2101 0.2 mg/kg Drug: IPH2101 2 mg/kg	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Multicenter Phase II Study on the Anti-tumor Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Fully Human Monoclonal Anti KIR Antibody, in Patients With Smoldering Multiple Myeloma (KIRMONO)

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Innate Pharma:

Primary Outcome Measures:

rate of patients achieving an objective response (defined according to the IMWG uniform response criteria) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess clinical safety of IPH2101 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
adverse events, physical examination and biological changes,during the whole clinical trial
Pharmacodynamics of IPH2101 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- KIR occupancy
- NK, B and T cell absolute number and percentage (immunophenotyping),
- NK cell functional assays
To document secondary anti-tumor parameters [ Time Frame: 3 years ] [ Designated as safety issue: No ]
any change of M protein in serum and/or urines occurring during the study

Estimated Enrollment:	30
Study Start Date:	September 2010
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IPH2101 0.2 mg/kg 0.2 mk/kg iv 6 cycles	Drug: IPH2101 0.2 mg/kg 0.2 mg/kg iv 6 cycles
Experimental: IPH2101 2 mg/kg 2 mg/kg iv 6 cycles	Drug: IPH2101 2 mg/kg 2 mg/kg iv 6 cycles

Eligibility

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

Criteria

Inclusion Criteria:

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)
Measurable disease defined as a disease with a serum M protein ≥ 1 g/dl
No evidence of fatigue, recurrent infections or any clinical suspicion of MM
Diagnosis of SMM confirmed on two consecutive assessments (ie fluctuation under 25% of serum protein level) performed with at least a 4 week interval.
Age > 18 years or < 75 years
ECOG performance status of 0 or 1
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
Informed consent signed by the patient

Exclusion Criteria:

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.
Use of any investigational agent within the last 3 months
Clinical laboratory values at screening
- Platelet < 75 x 109 /l
- ANC < 1.5 x 109 /l
- Bilirubin levels >1.5 ULN ; ALT and AST > 3 ULN (grade 1 NCI)
Primary or associated amyloidosis
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
Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen
History of or current auto-immune disease
History of other active malignancy within the past five years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma).
Serious concurrent uncontrolled medical disorder
History of allograft or solid organ transplantation
Pregnant or lactating women
Any condition potentially hampering compliance with the study protocol and follow-up schedule

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222286

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Innate Pharma

Investigators

Principal Investigator:

Nikhil Munshi, MD

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

More Information

No publications provided

Responsible Party:	Innate Pharma
ClinicalTrials.gov Identifier:	NCT01222286 History of Changes
Other Study ID Numbers:	IPH2101-203
Study First Received:	October 8, 2010
Last Updated:	October 11, 2011
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

ClinicalTrials.gov processed this record on May 24, 2012