Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma

Completed · Phase 2

Conditions studied: Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

This phase II trial studies how well bortezomib works in treating patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00075881

Run by

National Cancer Institute (NCI)

People needed

44

Starts

2004-01-01

Expected to finish

2012-10-01

Last updated by the study team

2014-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must not have received prior myeloma specific therapy (chemotherapy, radiotherapy, or biologic therapy) other than bisphosphonate therapy
• Patients may have received radiation of plasmacytoma (for example, solitary plasmacytoma); the last such treatment must have occurred >= 4 weeks prior to registration
• Patients must be recently diagnosed with symptomatic multiple myeloma confirmed by meeting one or more of the following criteria (obtained =< 30 days prior to registration):
• NOTE: serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP) and marrow biopsy all must be done at baseline in order to evaluate response
• Monoclonal protein in the serum >= 1 g/dl (measurable disease), or
• Monoclonal light chain in the urine protein electrophoresis >= 200 mg/24 hours (measurable disease), or
• Bone marrow plasmacytosis >= 30% without either of the values in above (evaluable disease)
• Patients must meet one or more of the following (all tests must be been drawn =< 30 days prior to registration but all results are not required to be available at time of registration as long as at least one of the following criteria has been met; if patient is otherwise eligible, plasma cell labeling index [PCLI] is not required, but is requested):
• Beta-2 microglobulin >= 5.5 mcg/mL, or
• PCLI >= 1, or
• Deletion 13 by cytogenetics
• Platelet count >= 20,000/mm\^3, with or without transfusion support
• Hemoglobin >= 7.0 g/dL, with or without transfusion support
• Absolute neutrophil count (ANC) >= 500/mm\^3 without growth factor support
• Direct bilirubin within =< 1.5 x upper normal limits (UNL)
• Alkaline phosphatase =< 2.5 x UNL
• Aspartate aminotransferase (AST) =< 2.5 x UNL
• Calculated or measured creatinine clearance >= 20 mL/minute
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2; exception: PS = 3 if secondary to acute bone event (fracture)
• Patients may not receive concurrent chemotherapy, radiotherapy or biologic therapy while on study; the exception for corticosteroids is made for those taking chronic corticosteroids for disorders other than myeloma, such as rheumatoid arthritis, adrenal insufficiency, etc.
• NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
• Patients must not have a history of allergic reaction attributable to compounds containing boron or mannitol
• Patient must not have a peripheral neuropathy > grade 1, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 3.0):
• Grade 2: Objective sensory (or motor) loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADL)
• Grade 3: Sensory (or motor) loss or paresthesia interfering with ADL

Where it is running

• Eastern Cooperative Oncology Group — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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