Know Cancer

or
forgot password

Multicenter Phase I Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101, a Human Monoclonal Anti-KIR, Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse


Phase 1
18 Years
80 Years
Open (Enrolling)
Both
Patients With Multiple Myeloma Experiencing a, First or Second Relapse

Thank you

Trial Information

Multicenter Phase I Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101, a Human Monoclonal Anti-KIR, Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse


Inclusion Criteria:



1. Signed informed consent obtained before any trial-related activities

2. Progressive disease or relapse of multiple myeloma (according to the IMWG definition)
after one or two prior therapeutic treatments or regimens for multiple myeloma that
achieved a response duration of at least 6 months

3. Prior therapeutic treatment regimens may have included Thalidomide and Lenalidomide.
Regarding patients previously treated by Lenalidomide, only patients who achieved at
least Partial Response duration of at least 6 months can be included. The patient
must not have discontinued treatment due to Lenalidomide intolerance.

4. Measurable disease, as indicated by one or more of the following:

- Serum M-protein ≥ 0.5 g/dL If Serum Protein Electrophoresis is felt to be
unreliable for routine M-protein measurement (particularly for patients with IgA
MM), then quantitative immunoglobulin levels can be accepted).

- Urine Bence-Jones protein ≥ 200 mg/24 h

- Involved serum Free Light Chains (sFLC) level ≥ 10 mg/dl ( ≥ 100 mg/l) provided
sFLC ratio is abnormal (<0.26 or >1.65)

5. ECOG performance status of 0, 1 or 2

6. Clinical laboratory values at screening

- Calculated creatinine clearance (according to MDRD) > 60 ml/min

- Platelet ≥ 75 x 109 /l for patients with < 50% BM plasma cells, and ≥
30 x 109 /l for patients with > 50% BM plasma cells

- ANC > 1 x 109 /l

- Bilirubin levels < 1.5 ULN ; ALT and AST < 3 ULN (grade 1 NCI)

7. Females of childbearing potential (FCBP)† must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to
and again within 24 hours of prescribing Lenalidomide (prescriptions must be filled
within 7 days) and must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control, one highly effective
method and one additional effective method AT THE SAME TIME, at least 28 days before
she starts taking Lenalidomide. FCBP must also agree to ongoing pregnancy testing.
Men must agree to use a latex condom during sexual contact with a FCBP even if they
have had a successful vasectomy

8. All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist®.

Exclusion Criteria:

1. Age < 18 years or > 80 years

2. Non secreting multiple myeloma or non measurable disease (< 0.5 g /dL M-Protein in
serum or < 200 mg urinary M-protein / 24 h or <10 mg/dl involved sFLC)

3. Life-threatening conditions related or not to MM relapse

4. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
while taking Lenalidomide)

5. Known hypersensitivity to thalidomide or IMiD®.

6. Use of any investigational agent within the last month

7. Treatment by systemic corticosteroids (except inhaled corticosteroids) or
chemotherapy (including consolidation and maintenance) within the last month (use of
biphosphonates is permitted)

8. Radiotherapy within the last month

9. Primary or associated amyloidosis

10. Peripheral neuropathy of grade ≥ 3 according to the CTCAE of the NCI

11. Abnormal cardiac status with any of the following

- NYHA stage III or IV congestive heart failure

- myocardial infarction within the previous 6 months

- cardiac arrhythmia remaining symptomatic despite treatment

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

13. History of or current auto-immune disease

14. History of other active malignancy within the past 5 years (apart from basal cell
carcinoma of the skin, or in situ cervix carcinoma)

15. Serious concurrent uncontrolled medical disorder

16. History of allograft or solid organ transplantation

17. Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule

18. Inability to comply with an antithrombotic regimen

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

number of patients with Dose Limiting Toxicity (DLT) at each dose level

Outcome Description:

safety of IPH2101 combined with lenalidomide at different dose levels.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Don Benson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Ohio State University Comprehensive Cancer Center - Columbus OH - USA

Authority:

United States: Food and Drug Administration

Study ID:

IPH2101-202

NCT ID:

NCT01217203

Start Date:

September 2010

Completion Date:

October 2015

Related Keywords:

  • Patients With Multiple Myeloma Experiencing a
  • First or Second Relapse
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Recurrence

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Mount Sinai Medical CenterNew York, New York  10029
NYU Clinical Cancer CenterNew York, New York  10016
Dana FarberBoston, Massachusetts  02115-6084
Saint Francis HospitalGreenville, South Carolina  29601
The Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210