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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)


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Smoldering Multiple Myeloma

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Trial Information

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)


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 109 /l

- ANC < 1.5 x 109 /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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

rate of patients achieving an objective response (defined according to the IMWG uniform response criteria)

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Nikhil Munshi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

IPH2101-203

NCT ID:

NCT01222286

Start Date:

September 2010

Completion Date:

September 2013

Related Keywords:

  • Smoldering Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Ohio State UniversityColumbus, Ohio  43210
Sarah Cannon Research InstituteNashville, Tennessee  37203