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

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

In Phase I, patients will receive a combination of PS-341 (Velcade) and R115777 (Zarnestra) to determine the dose limiting toxicity (DLT). Once DLT is determined, patients in Phase II will be receive the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue if there is evidence of continued response for 8 cycles. Patients will receive follow up to include normal laboratory evaluations at least every 3 months and a skeletal survey will be performed at least every 6 months.

Key facts

Study ID

NCT00361088

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

42

Starts

2005-08-01

Expected to finish

2007-06-01

Last updated by the study team

2013-11-25

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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