Status:
COMPLETED
Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well lenalidomide works with or wit...
Detailed Description
OBJECTIVES: Primary * To assess the progression-free survival at 1 year in patients with newly diagnosed symptomatic multiple myeloma treated with lenalidomide alone or in combination with dexametha...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Newly diagnosed multiple myeloma, meeting the following criteria:
- Symptomatic disease
- Previously untreated disease
- Measurable or evaluable disease, defined by ≥ 1 of the following:
- Serum monoclonal protein ≥ 1.0 g/dL
- Monoclonal protein \> 200 mg by 24-hour urine electrophoresis
- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa:lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
- Measurable soft tissue plasmacytoma, not previously radiated
- No monoclonal gammopathy of unknown significance or asymptomatic myeloma
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 (PS 3 allowed if secondary to pain)
- ANC ≥ 1,500/μL
- Platelet count ≥ 75,000/μL
- Creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective forms of contraception 28 days prior to, during and 28 days after study treatment
- Registered into the RevAssist® program and willing to comply with program requirements
- Able to take prophylactic aspirin (325 mg/day) or warfarin or low molecular weight heparin
- Willing to provide mandatory blood and bone marrow samples
- Willing to return for follow up
- No uncontrolled infection
- No NYHA class III or IV heart failure
- No active deep vein thrombosis that has not been therapeutically anticoagulated
- No known hypersensitivity to thalidomide
- No known HIV positivity
- No known hepatitis type A, B, or C infection
- No other prior active malignancy within the past 2 years, except currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- No development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior radiotherapy for solitary plasmacytoma
- More than 28 days since other prior experimental drug or therapy
- Prior clarithromycin, DHEA, anakinra, pamidronate, or zoledronic acid allowed
- No prior lenalidomide
- No prior cytotoxic chemotherapy
- No prior corticosteroids (≥ 160 mg of dexamethasone or equivalent) for this disease
- Prior corticosteroid for nonmalignant disease allowed
- Concurrent corticosteroids allowed (≤ 20 mg/day of prednisone or equivalent)
- Concurrent palliative radiotherapy for bone pain or fracture allowed
- No other concurrent anticancer agents or treatments
Exclusion
Key Trial Info
Start Date :
December 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2018
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00772915
Start Date
December 3 2008
End Date
June 27 2018
Last Update
January 18 2020
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905