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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT00691704
Eligibility Criteria:
Inclusion Criteria:
1. Understand and voluntarily sign an informed consent form.
2. Age 18 years or older at the time of signing the consent.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Multiple myeloma (MM) diagnosed according to the following standard criteria:
* Monoclonal plasma cells in bone marrow ≥10% and/or presence of biopsy-proven plasmacytoma
* Monoclonal protein present in serum and/or urine Myeloma-related organ dysfunction (1 or more) (C) Calcium elevation in blood (serum calcium \>10.5 mg/L or ULN) (R) Renal insufficiency (SCr \>2 mg/dL) (A) Anemia (hemoglobin \<10 g/dL or 2g \<normal) (B) Lytic bone lesions or osteoporosis
5. Measurable disease requiring systemic therapy.
6. High risk multiple myeloma defined by the presence of one or more of the following:
* Deletion of chromosome 13 by metaphase analysis (standard cytogenetics)
* deletion of 17p13 (p53) by Fluorescence in situ hybridization (FISH) or metaphase analysis
* t(4;14) by FISH
* t(14;16) by FISH
* t(8;14) by FISH
* t(14;20) by FISH
* hypodiploidy detected by FISH or metaphase analysis
* any complex cytogenetic abnormality detected by metaphase analysis, with the exception of hyperdiploidy
7. No previous treatment with systemic therapy or radiation therapy lasting more than 4 weeks duration.
8. At least 7 days since date of last radiation or systemic treatment for MM.
9. Eastern Cooperative Oncology Group (ECOG) performance status of \< or =2 at study entry.(0=Fully active; 1=Restricted but ambulatory; 2=Ambulatory but unable to work)
10. All study participants must be registered into the mandatory RevAssist® program, and willing and able to comply with the requirements.
11. Females of childbearing potential (FCBP) must have negative pregnancy test with a sensitivity of \>/=50 milli-International unit (mIU)/mL within 10-14 days prior to and within 24 hours of prescribing lenalidomide and must use 2 acceptable methods of birth control, one highly effective method and one other effective method AT THE SAME TIME, \>4 weeks before taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a latex condom even if he has had a successful vasectomy, if partner is FCBP.
12. Disease free of prior malignancies for \>5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
13. Able to take 325 mg aspirin daily as prophylactic anticoagulation for the duration of protocol therapy.
14. Receive concomitant therapy with bisphosphonates if bony lesions are present at time of enrollment.
Exclusion criteria
1. Any serious medical condition, laboratory abnormality, or psychiatric illness to prevent the subject from signing the consent.
2. Pregnant or breast feeding females.
3. Any condition which places the subject at unacceptable risk or confounds the ability to interpret data from the study.
4. Abnormal laboratory test results within these ranges:
* Absolute neutrophil count \< 1.0 x 109/L
* Platelet count \< 50 x 109/L (Subjects with severe pancytopenia (not meeting the above criteria) due to myeloma involvement of \> 70% bone marrow are eligible)
* Serum creatinine \> 2.5 mg/dL or ≥ 3.0 mg/dL if due to multiple myeloma.
* Total bilirubin \> 2.0 mg/dl
5. History of allergy to any of the study medications, their analogues, or excipients in the various formulations
6. Concurrent use of other anti-cancer agents or treatments.
7. Known HIV positivity
8. Known Active Hepatitis A, B or C
9. Erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00691704
Study Brief:
Protocol Section:
NCT00691704