Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This randomized phase III trial is studying bortezomib, dexamethasone, and lenalidomide to see how well they work compared with bortezomib and dexamethasone in treating patients with multiple myeloma previously treated with dexamethasone. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bortezomib together with dexamethasone is more effective with or without lenalidomide in treating multiple myeloma

Further Study Information

PRIMARY OBJECTIVES:

I. To compare the progression-free survival (PFS) of patients with previously treated symptomatic multiple myeloma treated with consolidation therapy comprising bortezomib and dexamethasone with vs without lenalidomide.

SECONDARY OBJECTIVES:

I. To determine the incremental ability of these regimens in attaining a complete response or a very good partial response (VGPR) in these patients.

II. To compare the overall survival of patients treated with these regimens. III. To compare the toxicity of these regimens in these patients. IV. To compare the quality of life of these patients. V. To examine the impact of differential treatment response, if observed, on quality of life of these patients.

VI. To obtain prospective data on multiple myeloma specific quality of life attributes.

OUTLINE: Patients are stratified according to prior induction therapy with lenalidomide and dexamethasone (yes vs no) and whether or not they are in complete response after induction therapy at study registration (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral lenalidomide once a day on days 1-14, and oral dexamethasone once a day on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral dexamethasone once a day on days 1-4. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed periodically. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of symptomatic multiple myeloma

• Must meet the following criteria at one point in the course of the disease for the original diagnosis of myeloma:

• Bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma

• Must have symptomatic disease that prompted the initiation of therapy (e.g., anemia, hypercalcemia, bone disease, or renal dysfunction)

• Must have completed a minimum of 1 and a maximum of 6 courses of a dexamethasone-based regimen within the past 8 weeks, including any of the following:

• Dexamethasone alone

• Vincristine, doxorubicin, and dexamethasone

• Thalidomide and dexamethasone

• Lenalidomide and dexamethasone

• Liposomal doxorubicin and dexamethasone

• The combination of any of the above agents and dexamethasone

• Cyclophosphamide, lenalidomide, and dexamethasone

• Received a minimum cumulative dose of 160 mg of dexamethasone (no maximum dose specified)

• Must have not experienced progressive disease on the dexamethasone-based regimen

• Patients diagnosed with only smoldering myeloma or monoclonal gammopathy of undetermined significance are not eligible

• ECOG performance status 0-2

• Hemoglobin > 7 g/dL

• Platelet count > 75,000/mm^3

• Absolute neutrophil count > 1,000/mm^3 (without the use of growth factors to increase ANC)

• Creatinine < 2.5 mg/dL and creatinine clearance (measured or calculated) ≥ 60 mL/min

• Direct bilirubin < 1.5 mg/dL

• ALT and AST < 2.5 times upper limit of normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double-method contraception for 4 weeks prior to, during, and for 4 weeks after completion of study therapy

• No active uncontrolled seizure disorder

• No seizure within the past 6 months

• No concurrent uncontrolled illness that would limit compliance with the study, including any of the following:

• Uncontrolled hypertension

• Symptomatic congestive heart failure

• Unstable angina

• Uncontrolled cardiac arrhythmia

• Uncontrolled psychiatric illness or social situation

• History of Steven Johnson syndrome

• No peripheral neuropathy ≥ grade 2

• No active uncontrolled infection

• Patients with a history of prior malignancy are eligible provided there is no active malignancy AND there is a low expectation of recurrence within 6 months

• Must be willing and able to receive prophylaxis with aspirin (325 mg/day) or alternative prophylaxis with low molecular weight heparin or coumadin

• Patients with prior DVT are eligible provided they remain on the anticoagulation regimen that was prescribed for treatment of the DVT throughout study therapy

• Concurrent bisphosphonates or growth factors (e.g., granulocyte and/or erythropoietic agents) for multiple myeloma allowed

• At least 14 days since prior palliative and/or localized radiotherapy

• Prior bortezomib allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Rafael Fonseca

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00522392
Information obtained from ClinicalTrials.gov on January 14, 2013

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