Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma
Condition: Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: bortezomib; laboratory biomarker analysis
Intervention description: Given IV; Optional correlative studies
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

               -  Grade 4: Permanent sensory (or motor) loss that interferes with function

          -  Patient must be capable of understanding the investigational nature, potential risks
             and benefits of the study

          -  Patient must have adequate cardiac function; patient must not have:

               -  History of a myocardial infarction within 6 months of enrollment

               -  New York Heart Association (NYHA) class III or IV heart failure

               -  Uncontrolled angina or electrocardiographic evidence of acute ischemia

               -  Severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of
                  active conduction system abnormalities

               -  Cardiac amyloidosis

          -  Patient must not have any other serious medical or psychiatric illness that could
             potentially interfere with the completion of treatment according to this protocol

          -  Patient must not have poorly controlled hypertension

          -  Women must not be pregnant or breast feeding; all females of childbearing potential
             must have a blood test or urine study within 7 days prior to registration to rule out
             pregnancy

          -  Women of childbearing potential and sexually active males must be strongly advised to
             use an accepted and effective method of contraception