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

Completed · Phase 2

Conditions studied: Smoldering Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01222286

Run by

Innate Pharma

People needed

30

Starts

2010-09-01

Expected to finish

2013-01-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• History of allograft or solid organ transplantation
• Pregnant or lactating women
• Any condition potentially hampering compliance with the study protocol and follow-up schedule

Where it is running

• 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

Full record on ClinicalTrials.gov

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