Lenalidomide With or Without Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

• Status: Completed
• Trial end date: 2018-06-27
• Target enrollment: 0
• Participant gender: All

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 without dexamethasone in treating patients with newly diagnosed multiple myeloma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

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