Status:
COMPLETED
Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma
Lead Sponsor:
Celgene Corporation
Collaborating Sponsors:
Prologue Research International
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Subjects who qualify for participation will receive lenalidomide with or without dexamethasone in 4 week cycles until disease progression is documented or lenalidomide becomes commercially available f...
Detailed Description
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated rel...
Eligibility Criteria
Inclusion
- Must understand and voluntarily sign an informed consent form.
- Must be \> or = to 18 years of age at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment.
- Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied.
- Measurable levels of myeloma paraprotein in serum (\>/=0.5 g/dL) or urine (\>/=0.2 g excreted in a 24-hour collection sample).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study medication.
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) \<1,000 cells/mm3 (1.0 x 109/L)
- Platelet count \<75,000/mm3 (75 x 109/L) for subjects in whom \<50% of the bone marrow nucleated cells are plasma cells.
- Platelet count \<30,000/mm3 (30x109/L) for subjects in whom \>/= 50% of bone marrow nucleated cells are plasma cells.
- Serum creatinine \>2.5 mg/dL (221 mmol/L)
- Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase \[AST\]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase \[ALT\]) \>3.0 x upper limit of normal (ULN)
- Serum total bilirubin \>2.0 mg/dL (34 mmol/L)
- Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for \>/= 1 year.
- Known hypersensitivity to thalidomide or dexamethasone.
- Prior history of uncontrollable side effects to dexamethasone therapy.
- The development of a desquamating rash while taking thalidomide.
- Use of any standard/experimental anti-myeloma drug therapy within 28 days of the initiation of study drug treatment or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of the initiation of study drug treatment.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
1913 Patients enrolled
Trial Details
Trial ID
NCT00179647
Start Date
September 1 2005
End Date
April 1 2009
Last Update
March 16 2010
Active Locations (69)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Alta Bates Cancer Center
Berkeley, California, United States, 94704
3
Scripps Cancer Center
La Jolla, California, United States, 93037
4
Cedar Sinai Medical CenterDept of Medicine
Los Angeles, California, United States, 90048