Tipifarnib and Bortezomib in Treating Patients With Relapsed Multiple Myeloma

Stopped early · Phase 1/Phase 2

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

In brief

This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with bortezomib and to see how well they work in treating patients with relapsed multiple myeloma. Tipifarnib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tipifarnib together with bortezomib may kill more cancer cells.

Key facts

Study ID

NCT00243035

Run by

National Cancer Institute (NCI)

People needed

64

Starts

2005-08-01

Last updated by the study team

2013-10-08

Who can join

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

You may qualify if…

• Diagnosis of multiple myeloma
• Stage II or III disease
• Relapsed disease after ≥ 2 prior therapies*, confirmed by the presence of 1 of the following:
• New lytic lesion
• A 25% increase in urine or serum monoclonal protein
• Patients who received prior bortezomib must have responded to therapy
• Measurable disease, defined by 1 or more of the following criteria:
• Serum M-component ≥ 1.0 g/dL by serum protein electrophoresis
• Urine M-protein excretion > 200 mg per 24-hour collection, by urine protein electrophoresis
• Performance status - Karnofsky 60-100%
• More than 8 weeks
• Platelet count ≥ 100,000/mm\^3
• Absolute neutrophil count ≥ 1,000/mm\^3
• Bilirubin ≤ 2 mg/dL
• Direct bilirubin ≤ 2 times upper limit of normal (ULN)
• AST or ALT ≤ 2 times ULN
• Creatinine ≤ 1.5 times ULN
• Calcium ≤ 12 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to swallow study medication
• Capable of following directions regarding study medication, or has a daily caregiver who will be responsible for administering study medication
• No peripheral neuropathy ≥ grade 2
• No hypersensitivity to any of the following:

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.