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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT00047203
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of relapsed or refractory multiple myeloma (MM) requiring treatment
* Durie-Salmon stage I or greater at diagnosis
* Patients with non-secretory or oligo-secretory MM (defined as maximum urinary M-spike less than 200 mg/24 hours and a maximum serum M-spike less than 0.5 g/dL during entire disease course) must have at least 30% bone marrow plasma cells
* Patients with secretory MM must have measurable disease defined as serum monoclonal protein of at least 1 g/dL or urinary M-spike of at least 200 mg/24 hours
* Must have received at least 1, but no more than 5 prior therapy regimens
* Patients who have had 4 or 5 regimens are allowed provided corticosteroids and/or thalidomide are part of the regimens
* No more than 5 prior chemotherapy regimens (as long as 2 contained dexamethasone or thalidomide)
* Prior autologous peripheral blood stem cell transplantation is considered 1 prior regimen
* Performance status - ECOG 0-2
* Performance status - ECOG 0-3 if secondary to neuropathy or acute bone event (e.g., vertebral compression or rib fracture)
* Absolute neutrophil count at least 750/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
* AST no greater than 2.5 times ULN
* Creatinine no greater than 3 mg/dL
* No myocardial infarction within the past 6 months
* Peripheral neuropathy secondary to prior drug therapy or myeloma-associated neuropathy allowed
* No other uncontrolled serious medical condition
* No uncontrolled infection
* No other active malignancy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* See Disease Characteristics
* No prior allogeneic stem cell transplantation
* At least 10 days since prior thalidomide
* No concurrent biologic therapy
* See Disease Characteristics
* At least 2 weeks since prior myelosuppressive chemotherapy
* No other concurrent chemotherapy
* See Disease Characteristics
* No concurrent corticosteroids (including as antiemetics) except chronic corticosteroids for disorders other than myeloma (e.g., rheumatoid arthritis or adrenal insufficiency)
* Maximum dose allowed for prednisone is no more than 10 mg/day or hydrocortisone no more than 40 mg/day
* At least 10 days since prior bortezomib or tipifarnib
* Concurrent bisphosphonates allowed if on stable dose before study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00047203
Study Brief:
Protocol Section:
NCT00047203