Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 3 December 2012
• Main ID: NCT00075881
• Date of registration: 09/01/2004
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma
• Scientific title: Phase II Study Of PS-341 For Patients With High-Risk, Newly Diagnosed Multiple Myeloma
• Date of first enrolment: January 2004
• Target sample size: 44
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00075881
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Australia, Peru, Puerto Rico, South Africa, United States

Contacts

• Name: Angela Dispenzieri, MD
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria

- Diagnosis of multiple myeloma meeting the following criteria:

- Symptomatic disease diagnosed within the past 30 days

- Measurable or evaluable disease meeting at least 1 of the following criteria:

- Serum monoclonal protein = 1 g/dL (measurable disease)

- Monoclonal light chain in urine protein electrophoresis = 200 mg/24-hour
urine collection (measurable disease)

- Bone marrow plasmacytosis = 30% (evaluable disease)

- High-risk disease, defined by = 1 of the following criteria:

- Beta 2-microglobulin = 5.5 µg/mL

- Plasma cell labeling index = 1%

- Deletion of chromosome 13 by cytogenetic analysis

- Age>=18

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (ECOG performance
status of 3 allowed if secondary to acute bone event [i.e., fracture])

- Adequate hematopoietic,hepatic, renal, cardiovascular function:

- Platelet count = 20,000/mm^3 (transfusion allowed)

- Hemoglobin = 7.0 g/dL (transfusion allowed)

- Absolute neutrophil count = 500/mm^3 (without growth factor support)

- Bilirubin = 1.5 times upper limit of normal (ULN)

- Aspartate aminotransferase (AST) = 2.5 times ULN

- Alkaline phosphatase = 2.5 times ULN

- Creatinine clearance = 20 mL/min

- Fertile patients must use effective contraception

- Concurrent corticosteroids allowed for treatment of chronic disorders other than
multiple myeloma (e.g., rheumatoid arthritis or adrenal insufficiency)

- Prior or concurrent bisphosphonates allowed

- Concurrent localized radiotherapy allowed upon approval by study chair

Exclusion criteria:

- Pregnant or nursing

- Positive pregnancy test

- Myocardial infarction within the past 6 months

- New York Heart Association class III or IV heart failure

- Uncontrolled angina

- Acute ischemia by electrocardiography (EKG)

- Severe uncontrolled ventricular arrhythmias

- Active conduction system abnormalities by EKG

- Cardiac amyloidosis

- Poorly controlled hypertension

- History of allergic reaction attributable to compounds containing boron or mannitol

- Greater than grade 1 peripheral neuropathy

- Other serious medical or psychiatric illness that would preclude study completion

- Prior biologic therapy for multiple myeloma

- Concurrent biologic therapy

- Concurrent pegfilgrastim

- Prior chemotherapy for multiple myeloma

- Concurrent chemotherapy

- Prior radiotherapy for multiple myeloma

- Less than 4 weeks since prior radiotherapy for plasmacytoma (e.g., solitary
plasmacytoma)

- Other concurrent antineoplastic therapy for multiple myeloma



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Plasma Cell Neoplasm

Intervention(s)

Drug: PS-341

Primary Outcome(s)

Response Rate on Induction [Time Frame: participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days]

Secondary Outcome(s)

1-year Progression Free Survival Probability [Time Frame: Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entry]

Response Rate on Maintenance [Time Frame: participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 days]

Response Rate on Reinduction [Time Frame: participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 days]

Secondary ID(s)

CDR0000349450

E2A02

U10CA021115

Source(s) of Monetary Support

Please refer to primary and secondary sponsors