Tipifarnib and Bortezomib in Treating Patients With Relapsed Multiple Myeloma

Inclusion Criteria

• •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:
• •* Bortezomib
• •* Boron
• •* Mannitol
• •* Imidazole compounds (e.g., clotrimazole, ketoconazole, miconazole, econazole)
• •No serious medical or psychiatric illness that would preclude study compliance
• •No other life-threatening illness (unrelated to tumor)
• •No other active or invasive malignancy within the past 3 years except for nonmelanoma skin cancer
• •No serious infection
• •No prior allogeneic bone marrow transplantation
• •More than 30 days since prior and no concurrent immunotherapy
• •More than 30 days since prior and no concurrent cytotoxic chemotherapy
• •More than 14 days since prior high-dose corticosteroids
• •No concurrent therapeutic corticosteroids (e.g., \> 10 mg prednisone per day)
• •No concurrent hormonal therapy
• •No concurrent antiemetic corticosteroids
• •More than 14 days since prior and no concurrent radiotherapy
• •More than 1 year since prior bortezomib
• •More than 14 days since prior investigational drugs
• •No prior tipifarnib
• •No other concurrent cancer-related treatment
• •No concurrent administration of the following enzyme-inducing anti-epileptic drugs:
• •* Phenytoin
• •* Phenobarbital
• •* Carbamazepine
• •No concurrent magnesium- or aluminum-based antacids within 2 hours before or after tipifarnib administration
• •Concurrent pamidronate or other bisphosphonates allowed