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:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT00017602
Eligibility Criteria:
DISEASE CHARACTERISTICS: NOTE: This trial is being conducted at many institutions throughout the country. Please contact Genta for a site near you.
* Progressive multiple myeloma defined by one of the following:
* Primary resistance or progressive disease after achieving less than a partial response after at least 2 courses of combination chemotherapy (that included at least 1 myelosuppressive drug) within the past 3 months
* Relapsed or progressive disease after at least a partial response to prior therapy
* Progressive disease after high-dose chemotherapy and autologous stem cell transplantation
* Progressive disease defined by at least 1 of the following:
* Increase in serum M-protein by at least 50% or at least 2 g/dL above the lowest remission or baseline level
* Increase in urinary M-protein by at least 50% or at least 2 g/24 hours above lowest remission or baseline level
* Appearance of new lytic bone lesions or at least 50% increase in size of an existing bone lesion
* Quantifiable serum and/or urine paraprotein
* Bone marrow plasmacytosis at least 5% of total nucleated cells
* Measurable disease
* Serum M-protein level at least 1.0 g/dL OR
* Urinary M-protein excretion at least 200 mg/24 hours
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-3
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 50,000/mm3
* No bleeding or coagulation disorder
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
* PT and PTT no greater than 1.5 times ULN
* No history of chronic hepatitis or cirrhosis
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No active symptoms of coronary artery disease (e.g., uncontrolled arrhythmias or recurrent chest pain despite prophylactic medication)
* No New York Heart Association class III or IV heart disease
* No uncontrolled congestive heart failure
* No grade 2 or greater cardiovascular signs or symptoms within the past 4 weeks
Other:
* HIV negative
* No active peptic ulcer disease
* No uncontrolled seizure disorder
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No active uncontrolled infection
* No active autoimmune disease
* No hypersensitivity to phosphorothioate-containing oligonucleotides or to dexamethasone
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* At least 3 weeks since prior immunotherapy
* At least 72 hours since prior thalidomide
* Concurrent epoetin alfa allowed
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
Endocrine therapy:
* At least 3 weeks since prior corticosteroids
* No concurrent chronic corticosteroids
Radiotherapy:
* At least 14 days since prior radiotherapy except limited radiotherapy to a single bone lesion
Surgery:
* At least 3 weeks since prior major surgery
* No prior organ allograft
Other:
* At least 4 weeks since other prior investigational therapy
* No more than 6 prior therapies for myeloma
* No concurrent immunosuppressive therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00017602
Study Brief:
Protocol Section:
NCT00017602