Status:
COMPLETED
A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Pfizer
Conditions:
Multiple Myeloma
Plasma Cell Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a 2-phase study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL), who have already received at least two previous treatments, will receive ...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria (Part 3):
- Patients should have received at least two prior treatment regimens.
- Confirmed refractory MM (measurable disease) or PCL. Patients must be refractory to treatment with both lenalidomide/dexamethasone and bortezomib/dexamethasone (or to treatment with bortezomib/lenalidomide/dexamethasone), defined as documented progressive disease on therapy or within 60 days of completing treatment with these regimens.
- Previously received adequate alkylator therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate hematology laboratory values without transfusion support within 2 weeks of screening.
- Adequate liver and renal function.
- Additional criteria exist.
- Key Exclusion Criteria (Part 3):
- Primary amyloidosis.
- Concomitant malignancies or previous malignancies with less than a 3-year disease free interval at the time of enrollment (patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low grade prostate cancer may enroll irrespective of the time of diagnosis).
- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug.
- Cytotoxic therapy or monoclonal antibodies within 21 days prior to first dose of study drug.
- Radiotherapy within 21 days prior to first dose of study drug (if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy).
- Corticosteroid doses \> 10 mg/day of prednisone or equivalent within 2 weeks prior to first dose of study drug.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
- Additional criteria exist.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2016
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00821249
Start Date
January 1 2009
End Date
March 16 2016
Last Update
October 19 2020
Active Locations (5)
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1
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030