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

NCT01222286 | Completed Phase 2 Results

• 1 other identifier: IPH2101-203
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

Smoldering Multiple Myeloma

Keywords

Smoldering Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Rate of Patients Achieving an Objective Response

  The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.

  from start to end of study (14 months)

Secondary Outcomes (3)

• Safety Assessment

  Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months

• Pharmacodynamics of IPH2101

  from start to end of study (14 months)

• Secondary Anti-tumor Activity

  from start to end of study (14 months)

Study Arms (2)

IPH2101 0.2 mg/kg

EXPERIMENTAL

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

Drug: IPH2101

IPH2101 2 mg/kg

EXPERIMENTAL

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

Drug: IPH2101

Interventions

IPH2101 DRUG

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

Also known as: a human monoclonal anti-KIR antibody (1-7F9)

IPH2101 0.2 mg/kg; IPH2101 2 mg/kg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 10\^9 /l
• ANC \< 1.5 x 10\^9 /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
• NYHA stage III or IV congestive heart failure
• myocardial infarction within the previous 6 months
• 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

Sponsors & Collaborators

• Innate Pharma: lead

Study Sites (5)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Smoldering Multiple Myeloma

Interventions

IPH-2101

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr Renaud Buffet
• Organization: Innate Pharma

renaud.buffet@innate-pharma.fr

33 4 30 30 30 32

Study Officials

• Nikhil Munshi, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 18, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2013
• Last Updated: May 14, 2026
• Results First Posted: May 9, 2014

Record last verified: 2026-04

Locations

US (5)