A Combination of Zarnestra With Velcade for Patients With Relapsed Multiple Myeloma
Multiple Myeloma

About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Velcade (PS-341), Bortezomib, Zarnestra (R115777), Tipifarnib
Eligibility Criteria
Inclusion Criteria: Voluntary written informed consent Female subject is either post-menopausal/surgically sterilized or willing to use an acceptable method of birth control for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study. Diagnosis of stage II or III multiple myeloma and have relapsed after at least one prior therapies confirmed by the presence of: A new lytic lesion A 25% increase in urine or serum monoclonal protein Patient can have received PS-341 (Velcade) previously and does not require a previous response. Patients must have measurable disease. One or more of the following must be present to qualify for this study: Serum M-component greater than or equal to 1.0 gm/dl (10.0 g/L) by serum protein electrophoresis Urine M-protein excretion > 200 mg/24 (0.2 g/24h) hours, by urine protein electrophoresis Abnormal serum free light chain ratio with elevated Kappa or Lambda light chains in serum Baseline measurements must be done within 21 days of study entry. Karnofsky Performance Status Scale > 60. Greater than or equal to 18 years of age. Expected survival of greater than 8 weeks. Swallow intact study medication tablets. Can follow directions or has a caregiver who will be responsible for administering study medication. Exclusion Criteria: Previously treated with R115777 (Zarnestra). Undergone an allogeneic bone marrow transplant. A platelet count of <100,000 x 10 to the 9 power/L within 14 days before enrollment. Absolute neutrophil count of <1.0 x 10 to the 9 power/L within 14 days before enrollment. Measured creatinine > 1.5 X the upper limits of normal within 14 days before enrollment. Greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment. Hypersensitivity to bortezomib, boron, mannitol or imidazole compounds Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Received other investigational drugs within 14 days of enrollment or immunotherapy within 30 days of enrollment. Serious medical or psychiatric illness likely to interfere with participation in this clinical study. Ongoing radiation therapy or radiation therapy within 14 days prior to first treatment. Cytotoxic chemotherapy within 30 days prior to first treatment. Therapy with high-dose corticosteroids within 14 days prior to first treatment. Presence of any of the following excludes a patient from entering the study until such condition is resolved (determined within 14 days prior to the first treatment): Elevated total bilirubin > 2mg/dl, or direct bilirubin > 2 times the ULN. Serum glutamic oxaloacetic transaminase (AST, formerly SGOT) or serum glutamic pyruvic transaminase (ALT, formerly SGPT) > 2 times the ULN Serum calcium > 12 mg/dL. Concurrent serious infection. Life-threatening illness (unrelated to tumor). History of any other ACTIVE and INVASIVE cancer other than the present condition (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years. Prohibited/allowable medications or precautions: Enzyme-inducing anti-epileptic medications (e.g. phenytoin, phenobarbital, carbamazepine) are not allowed. Non-enzyme anti-epileptic medications will be allowed.
Sites / Locations
- H. Lee Moffitt Cancer Center & Research Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase I
Phase II