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Complete title: A Phase 1/2 Study Of Arry-520 In Patients With Relapsed Or Refractory Multiple Myeloma
|Research Study Number||2402.00|
|Principal Investigator||Bill Bensinger, MD|
Research Study Description
ARRY-520 is designed to prevent cancer cells from reproducing. By preventing the tumor cells from reproducing, ARRY-520 may slow the spread of the cancer cells and may cause them to die. ARRAY-520-212 is a study meant for patients with relapsed or refractory multiple myeloma or plasma cell leukemia, who have already received at least two previous treatments. Prior treatments should include bortezomib and an immunomodulatory agent, such as thalidomide and/or lenalidomide, unless the patients were not eligible or refused to receive those treatments. In the first part of this study, patients will receive increasing doses of a novel kinesin spindle protein inhibitor (KSP inhibitor) in order to achieve the highest dose possible that will not cause unacceptable side effects. In the second part of the study, a larger group of patients will receive the best dose determined from the first part of the study. Both groups of patients will be followed to see what side effects ARRY-520 causes and to see what effectiveness it has, if any in treating the cancer.
Eligibility Criteria (must meet the following to participate in this study)
- Measurable MM disease, defined as one of the following: A monoclonal immunoglobulin (Ig) concentration on serum electrophoresis of = 1.0 g/dL for an IgG myeloma, 0.5 g/dL for an IgA myeloma, and 0.1 g/dL for an IgD myeloma; Measurable urinary light chain secretion by quantitative analysis of = 200 mg/24 hours; Involved serum free light chain (FLC) level = 10 mg/dL, provided the serum FLC ratio is abnormal; Patients with oligo- or non-secretory disease must have bone marrow involvement with at least 30% plasmacytosis on aspiration.
- Male or female, = 18 years of age at time of signing consent.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate hematology laboratory values without transfusion support within two weeks of screening: Hemoglobin = 8 g/dL; Absolute neutrophil count (ANC) = 1.5 x 109/L; Platelets = 75 x 109/L.
- Adequate liver and renal function: Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) = 2.5 x the upper limit of normal (ULN); Bilirubin < 1.5 mg/dL; Serum creatinine = 2.5 mg/dL, and a calculated creatinine clearance of at least 50 mL/min (using the Cockcroft and Gault method).
- If patient is female and of childbearing potential, she must have a negative serum beta human chorionic gonadotropin (ß HCG) test.
- Male patients and female patients of childbearing potential must agree to use an effective method of contraception per institutional standard.
- Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Concomitant malignancies or previous malignancies with less than a three-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.
- Treatment with an investigational product or device within 28 days of initiating 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. However, if the radiation portal covered = 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy.
- Major surgery within two weeks prior to first dose of study drug.
- Corticosteroid doses > 10 mg/day within two weeks prior to first dose of study drug.
- Any serious medical or psychiatric disorder that would interfere with patient safety or informed consent.
- Any severe concurrent disease or condition (including active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia), which, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- Known positive serology for the Human Immunodeficiency Virus (HIV), Hepatitis B and/or active Hepatitis C.
Other exclusion criteria may apply.
Hematologic Malignancies; Multiple Myeloma (MM)
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