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Seattle, Washington 98109


RATIONALE: PS-341 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known if PS-341 is effective in treating patients who have multiple myeloma. PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have refractory or progressive multiple myeloma.

Study summary:

OBJECTIVES: - Determine the time to progressive disease in patients with refractory or progressive multiple myeloma treated with PS-341. - Determine the safety and tolerability of this drug in these patients. - Determine survival of patients treated with this drug. - Determine the rate and duration of response (complete and partial) in patients treated with this drug. - Assess the relationship between selected genetic disease markers and response in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. - Induction therapy: Patients receive PS-341 IV on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses. - Maintenance therapy: Patients receive PS-341 IV on days 1, 8, 15, and 22. Treatment repeats every 5 weeks for up to 3 courses. Patients who experience progressive disease (PD) after at least 2 courses or no change after at least 4 courses may also receive oral dexamethasone on the day of and the day after PS-341 administration. Patients who experience PD after at least 2 courses of this combined therapy go off study. Patients are followed at 30 days, every 6 weeks until disease progression, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 1 year.


DISEASE CHARACTERISTICS: - Diagnosis of multiple myeloma (MM) and meeting 1 of the following criteria: - Progressive disease during or after treatment with high-dose dexamethasone on MPI Study M34101-039 (FHCRC-1746.00), with no other antineoplastic treatment for MM initiated - Relapsed or progressive disease after receiving at least 4 prior treatment regimens for MM (non-MPI patients) PATIENT CHARACTERISTICS: Age - Adult Performance status - Karnofsky 60-100% (non-MPI patients) Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 500/mm^3 (no growth factor support) - Platelet count at least 20,000/mm^3 (transfusions allowed) - Hemoglobin at least 7.0 g/dL (transfusions allowed) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN - Hepatitis B surface antigen negative - No known active hepatitis C infection Renal - Calcium less than 14 mg/dL - Creatinine clearance at least 20 mL/min Cardiovascular - Non-MPI patients: - No myocardial infarction within the past 6 months - No New York Heart Association class III or IV heart failure - No uncontrolled angina - No severe uncontrolled ventricular arrhythmias - No acute ischemia or active conduction system abnormalities by EKG - No cardiac amyloidosis - No poorly controlled hypertension Other - All patients: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - Non-MPI patients: - No other serious medical or psychiatric illness that would preclude study - No prior allergic reaction attributable to compounds containing boron or mannitol - No peripheral neuropathy grade 2 or greater - No diabetes mellitus - No active systemic infection requiring treatment - MPI patients: - Recovered from dexamethasone-related toxicity - No other new or worsening existing illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior immunotherapy or antibody therapy (non-MPI patients) - No concurrent thalidomide Chemotherapy - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) (non-MPI patients) Endocrine therapy - See Disease Characteristics - At least 3 weeks since prior corticosteroids (greater than 10 mg/day of prednisone or equivalent) (non-MPI patients) - No other concurrent corticosteroids (e.g., greater than 10 mg/day of prednisone or equivalent) Radiotherapy - Concurrent local short-duration radiotherapy allowed Surgery - At least 4 weeks since prior major surgery (except kyphoplasty) (non-MPI patients) - Concurrent kyphoplasty allowed - Concurrent emergency orthopedic procedures allowed Other - No other concurrent antineoplastic treatment for MM - No other concurrent investigational agents, including commercial agents approved for other indications but investigational for MM - No concurrent clarithromycin - Concurrent bisphosphonates allowed



Primary Contact:

Study Chair
Denise Collins
Millennium Pharmaceuticals, Inc.

Backup Contact:


Location Contact:

Seattle, Washington 98109
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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