S0833, Bortezomib, Thalidomide, Lenalidomide, Combination Chemotherapy, and Autologous Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

• Status: Withdrawn
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide and lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, cisplatin, doxorubicin hydrochloride, cyclophosphamide, etoposide, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving bortezomib, thalidomide, and combination chemotherapy before and after transplant and lenalidomide after transplant may be an effective treatment for multiple myeloma.

PURPOSE: This phase II trial is studying how well giving bortezomib, thalidomide, and lenalidomide together with combination chemotherapy and autologous stem cell transplant works in treating patients with newly diagnosed multiple myeloma.

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

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib; Cisplatin; Cyclophosphamide; Dexamethasone; Doxorubicin; Etoposide; Etoposide phosphate; Lenalidomide; Liposomal doxorubicin; Melphalan; Thalidomide

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed active multiple myeloma (MM)

• Measurable disease

• Non-secretory disease allowed provided patient has ≥ 20% plasmacytosis or multiple (> 3) focal plasmacytomas on skeletal survey and/or MRI

PATIENT CHARACTERISTICS:

• Zubrod performance status (PS) 0-2 (Zubrod PS 3-4 allowed if based solely on bone pain)

• ANC ≥ 1,500/mm^3*

• Platelet count ≥ 150,000/mm^3*

• Serum creatinine clearance of ≥ 60 mL/min

• Patients with creatinine clearance of < 60 mL/min receive a lower dose of melphalan

• No patients receiving or planning to receive dialysis

• Total bilirubin ≤ 1.5 times upper limit of normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Must be fully aware of the teratogenic potential of thalidomide

• Must be willing to comply with the FDA-mandated S.T.E.P.S. program

• Ejection fraction > 40% as measured by MUGA scan or two-dimensional ECHO

• No peripheral neuropathy ≥ grade 2 per CTCAE v. 4.0

• No known hypersensitivity to bortezomib, boron, or mannitol

• No uncontrolled diabetes defined as fasting glucose level > 200 mg/dL on at least more than two occasions or more that two serum random blood levels > 300 mg/dL despite adequate treatment

• Patients with a history of diabetes mellitus requiring treatment should be on a stable regimen and have their blood glucose closely monitored

• No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment within the past year NOTE: *Unless myeloma-related marrow infiltration is documented, defined as ≥ 30% marrow cellularity with 50% of the cells being malignant plasma cells.

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior chemotherapy or radiotherapy

• No more than 1 prior course of chemotherapy for MM

• Prior chemotherapy must not have included melphalan

• No prior radiotherapy to large area of the pelvis (more than half of the pelvis)

• Prior radiotherapy for symptomatic localized bone lesions or impending cord compression allowed