Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT00243035
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00243035
Study Brief:
Protocol Section:
NCT00243035