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Last Modified: 9/4/2008     First Published: 8/25/2007  
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Phase III Randomized Study of Consolidation Therapy Comprising Bortezomib and Dexamethasone With Versus Without Lenalidomide in Patients With Symptomatic Multiple Myeloma Who Have Completed a Dexamethasone-Based Induction Regimen

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Bortezomib and Dexamethasone With or Without Lenalidomide in Treating Patients With Multiple Myeloma Previously Treated With Dexamethasone

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III


Treatment


Active


18 and over


NCI


ECOG-E1A05
E1A05, NCT00522392

Special Category: CTSU trial, NCI Web site featured trial

Objectives

Primary

  1. 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

  1. To determine the incremental ability of these regimens in attaining a complete response or a very good partial response (VGPR) in these patients.
  2. To compare the overall survival of patients treated with these regimens.
  3. To compare the toxicity of these regimens in these patients.
  4. To compare the quality of life of these patients.
  5. To examine the impact of differential treatment response, if observed, on quality of life of these patients.
  6. To obtain prospective data on multiple myeloma specific quality of life attributes.

Entry Criteria

Disease Characteristics:

  • 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 4 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 600 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


Prior/Concurrent Therapy:

  • See Disease Characteristics
  • At least 14 days since prior palliative and/or localized radiotherapy
  • No prior bortezomib
  • Concurrent bisphosphonates or growth factors (e.g., granulocyte and/or erythropoietic agents) for multiple myeloma allowed

Patient Characteristics:

  • ECOG performance status 0-2
  • Hemoglobin > 7 g/dL
  • Platelet count > 75,000/mm3
  • Absolute neutrophil count > 1,000/mm3 (without the use of growth factors to increase ANC)
  • Creatinine < 2.5 mg/dL
  • 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

Expected Enrollment

392

Outcomes

Primary Outcome(s)

Progression-free survival

Secondary Outcome(s)

Response rates (complete response and very good partial response)
Overall survival rates
Difference in rate of all grade 3 or higher toxicity
Difference in the mean change in the FACT-Ntx TOI score from study registration (prior to randomization) to 6 months post-consolidation treatment
Impact of the differential treatment survival on quality of life at clinically meaningful timepoints (i.e., prior to study randomization, at the beginning of course 5, at the end of course 8, and at 3, 6, 9, and 12 months after treatment)

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Rafael Fonseca, MD, Protocol chair
Ph: 480-301-6118
Email: fonseca.rafael@mayo.edu
S. Rajkumar, MD, Protocol chair
Ph: 507-284-8430
Email: rajks@mayo.edu

Trial Sites

U.S.A.
Alabama
  Mobile
 Providence Cancer Center at Providence Hospital
 Paul Schwarzenberger, MD
Ph: 251-435-5892
Alaska
  Anchorage
 Providence Cancer Center
 Clinical Trials Office - Providence Cancer Center
Ph: 907-261-3109
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
California
  Fairfield
 North Bay Cancer Center
 Clinical Trials Office - North Bay Cancer Center
Ph: 707-429-6976
  San Diego
 Kaiser Permanente Medical Office -Vandever Medical Office
 Han Koh
Ph: 619-528-2596
Colorado
  Aurora
 Aurora Presbyterian Hospital
 Eduardo Pajon, MD
Ph: 303-777-2663
  Boulder
 Boulder Community Hospital
 Clinical Trials Office - Boulder Community Hospital
Ph: 303-938-5253
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Clinical Trials Office - Penrose Cancer Center
Ph: 719-776-5275
  Denver
 CCOP - Colorado Cancer Research Program
 Eduardo Pajon, MD
Ph: 303-777-2663
 Porter Adventist Hospital
 Eduardo Pajon, MD
Ph: 303-777-2663
 Presbyterian - St. Luke's Medical Center
 Clinical Trials Office - Presbyterian - St. Luke's Medical Center
Ph: 303-839-6000
 Rose Medical Center
 Eduardo Pajon, MD
Ph: 303-777-2663
 St. Anthony Central Hospital
 Eduardo Pajon, MD
Ph: 303-777-2663
 St. Joseph Hospital
 Eduardo Pajon, MD
Ph: 303-777-2663
  Englewood
 Swedish Medical Center
 Eduardo Pajon, MD
Ph: 303-777-2663
  Fort Collins
 Front Range Cancer Specialists
 Diana Medgyesy, MD
Ph: 970-212-7600
 Poudre Valley Hospital
 Clinical Trials Office - Poudre Valley Hospital
Ph: 970-495-8226
  Grand Junction
 St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
 Eduardo Pajon, MD
Ph: 303-777-2663
  Greeley
 North Colorado Medical Center
 Eduardo Pajon, MD
Ph: 303-777-2663
  Lone Tree
 Sky Ridge Medical Center
 Eduardo Pajon, MD
Ph: 303-777-2663
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Eduardo Pajon, MD
Ph: 303-777-2663
  Loveland
 McKee Medical Center
 Eduardo Pajon, MD
Ph: 303-777-2663
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Eduardo Pajon, MD
Ph: 303-777-2663
  Thornton
 North Suburban Medical Center
 Eduardo Pajon, MD
Ph: 303-777-2663
  Wheat Ridge
 Exempla Lutheran Medical Center
 Clinical Trials Office - Exempla Lutheran Medical Center
Ph: 303-403-3605
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Clinical Trials Office - Tunnell Cancer Center
Ph: 302-645-3171
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-733-6227
Florida
  Fort Lauderdale
 Broward General Medical Center Cancer Center
 Clinical Trials Office - Broward General Medical Center Cancer Center
Ph: 954-355-5346
  Jacksonville
 Mayo Clinic - Jacksonville
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Georgia
  Atlanta
 CCOP - Atlanta Regional
 Thomas Seay, MD, PhD
Ph: 404-851-2340
 Northside Hospital Cancer Center
 Clinical Trials Office - Northside Hospital Cancer Center
Ph: 404-303-3355
 Piedmont Hospital
 Thomas Seay, MD, PhD
Ph: 404-851-2340
 Saint Joseph's Hospital of Atlanta
 Clinical Trials Office - Saint Joseph's Hospital of Atlanta
Ph: 404-851-7115
  Austell
 WellStar Cobb Hospital
 Clinical Trials Office - WellStar Cobb Hospital
Ph: 770-793-5980
  Decatur
 Charles B. Eberhart Cancer Center at DeKalb Medical Center
 Thomas Seay, MD, PhD
Ph: 404-851-2340
  Lawrenceville
 Gwinnett Medical Center
 Thomas Seay, MD, PhD
Ph: 404-851-2340
  Marietta
 Kennestone Cancer Center at Wellstar Kennestone Hospital
 Clinical Trials Office - Kennestone Cancer Center
Ph: 770-793-5980
  Riverdale
 Southern Regional Medical Center
 Clinical Trials Office - Southern Regional Medical Center
Ph: 770-991-8611
Illinois
  Alton
 Saint Anthony's Hospital at Saint Anthony's Health Center
 Bethany Sleckman, MD
Ph: 314-251-6573
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith Rowland, MD
Ph: 217-383-3010
  Bloomington
 St. Joseph Medical Center
 John Kugler, MD
Ph: 309-243-3000
  Canton
 Graham Hospital
 John Kugler, MD
Ph: 309-243-3000
  Carthage
 Memorial Hospital
 John Kugler, MD
Ph: 309-243-3000
  Chicago
 Swedish Covenant Hospital
 Contact Person
Ph: 773-878-8200
  Elk Grove Village
 Alexian Brothers Radiation Oncology
 Bruce Bank, MD
Ph: 847-437-3312
  Eureka
 Eureka Community Hospital
 John Kugler, MD
Ph: 309-243-3000
  Galesburg
 Galesburg Clinic, PC
 John Kugler, MD
Ph: 309-243-3000
 Galesburg Cottage Hospital
 John Kugler, MD
Ph: 309-243-3000
  Havana
 Mason District Hospital
 John Kugler, MD
Ph: 309-243-3000
  Hinsdale
 Hinsdale Hematology Oncology Associates
 Elyse Schneiderman, MD
Ph: 630-654-1790
  Hopedale
 Hopedale Medical Complex
 John Kugler, MD
Ph: 309-243-3000
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kendrith Rowland, MD
Ph: 217-383-3010
  Macomb
 McDonough District Hospital
 John Kugler, MD
Ph: 309-243-3000
  Moline
 Costas Constantinou, MD
 Costas Constantinou, MD
Ph: 916-734-2781
 Costas Constantinou, MD
Ph: 309-779-4265
 Costas Constantinou, MD
Ph: 309-779-5090
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 Costas Constantinou, MD
Ph: 309-779-5092
  Mt. Vernon
 Good Samaritan Regional Health Center
 Bethany Sleckman, MD
Ph: 314-251-6573
  Normal
 BroMenn Regional Medical Center
 John Kugler, MD
Ph: 309-243-3000
 Community Cancer Center
 John Kugler, MD
Ph: 309-243-3000
  Ottawa
 Community Hospital of Ottawa
 John Kugler, MD
Ph: 309-243-3000
 Oncology Hematology Associates of Central Illinois, PC - Ottawa
 John Kugler, MD
Ph: 309-243-3000
  Pekin
 Cancer Treatment Center at Pekin Hospital
 John Kugler, MD
Ph: 309-243-3000
  Peoria
 CCOP - Illinois Oncology Research Association
 John Kugler, MD
Ph: 309-243-3000
 Methodist Medical Center of Illinois
 Clinical Trials Office - Methodist Medical Center of Illinois
Ph: 309-243-3000
 Oncology Hematology Associates of Central Illinois, PC - Peoria
 John Kugler, MD
Ph: 309-243-3000
 OSF St. Francis Medical Center
 John Kugler, MD
Ph: 309-243-3000
 Proctor Hospital
 John Kugler, MD
Ph: 309-243-3000
  Peru
 Illinois Valley Community Hospital
 John Kugler, MD
Ph: 309-243-3000
  Princeton
 Perry Memorial Hospital
 John Kugler, MD
Ph: 309-243-3000
  Rockford
 Swedish-American Regional Cancer Center
 Clinical Trials Office - Swedish-American Regional Cancer Center
Ph: 815-489-4413
  Spring Valley
 St. Margaret's Hospital
 John Kugler, MD
Ph: 309-243-3000
  Springfield
 Regional Cancer Center at Memorial Medical Center
 Clinical Trials Office - Regional Cancer Center at Memorial Medical Center
Ph: 217-788-4233
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Clinical Trials Office - Carle Cancer Center
Ph: 800-446-5532
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard Gross, MD
Ph: 317-787-3311
  Fort Wayne
 Fort Wayne Medical Oncology and Hematology
 Sreenivasa Nattam, MD
Ph: 260-484-8830
800-852-2333
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Clinical Trials Office - Indiana University Cancer Center
Ph: 317-274-2552
 Veterans Affairs Medical Center - Indianapolis
 Rafat Abonour, MD
Ph: 317-274-0843
 William N. Wishard Memorial Hospital
 Rafat Abonour, MD
Ph: 317-274-0843
  Michigan City
 Saint Anthony Memorial Health Centers
 Kendrith Rowland, MD
Ph: 217-383-3010
  Munster
 Community Hospital
 Erwin Robin, MD
Ph: 219-836-4503
  Richmond
 Reid Hospital & Health Care Services
 Howard Gross, MD
Ph: 765-983-3000
Iowa
  Ames
 McFarland Clinic, PC
 Clinical Trials Office - McFarland Clinic, PC
Ph: 515-239-2621
  Bettendorf
 Costas Constantinou, MD
Ph: 563-421-1960
  Des Moines
 CCOP - Iowa Oncology Research Association
 Roscoe Morton, MD, FACP
Ph: 515-244-7586
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital
Ph: 515-241-8704
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center
Ph: 515-241-6727
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-244-7586