Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma
NCT ID: NCT01530594
Last Updated: 2016-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
440 participants
INTERVENTIONAL
2009-01-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lenalidomide
Lenalidomide/Low dose Dex (LLD)
Lenalidomide/Low dose Dex
Lenalidomide/Low dose Dex (LLD)
Lenalidomide
Lenalidomide/Low dose Dex (LLD
Bortezomib/Lenalidomide
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
Bortezomib/Lenalidomide/ Low dose Dex
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
Interventions
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Lenalidomide/Low dose Dex
Lenalidomide/Low dose Dex (LLD)
Bortezomib/Lenalidomide/ Low dose Dex
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
Lenalidomide
Lenalidomide/Low dose Dex (LLD
Eligibility Criteria
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Inclusion Criteria
2. Patients must have received no prior chemotherapy for this disease. Patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis). Prior steroid treatment is allowed provided treatment was not more than 2 weeks in duration. Patients must not have received any prior treatment with bortezomib or lenalidomide.
3. Patients must be ≥ 18 years of age at the time of registration.
4. Patients must have a Zubrod Performance Status (PS) of 0 - 3
5. Patients must have adequate marrow function as defined herein:
6. Platelet count ≥ 80 x 103/mcL,
7. ANC ≥ 1 x 103/mcL, and Hemoglobin (including patients who have been either transfused or treated with EPO) ≥ 9 g/dL.
8. Institutions must submit a local cytogenetics report and FISH analysis report
9. Patients with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity.
10. Patients must have a calculated or measured creatinine clearance \> 30 cc/min.
11. Patients must not have uncontrolled, active infection requiring intravenous antibiotics
12. Patients must not have any psychiatric illness
13. Patients must not be Hepatitis B, Hepatitis C or HIV positive
14. Patients must not have a history of cerebral vascular accident with persistent neurologic deficits.
15. Patients must be able to take aspirin 325 mg daily
16. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
17. No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
18. Patients must be offered participation in GEP molecular studies for the evaluation of genetic polymorphisms.
18 Years
80 Years
ALL
No
Sponsors
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King Faisal Specialist Hospital & Research Center
OTHER
Responsible Party
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Locations
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King Faisal Specialist Hospital &Reseach Center
Riyadh, , Saudi Arabia
Countries
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Other Identifiers
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2081-113
Identifier Type: -
Identifier Source: org_study_id
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