S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT ID: NCT00124579

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2010-06-30

Brief 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, may stimulate the immune system in different ways and stop cancer cells from growing. It may also stop the growth of cancer by blocking blood flow to the cancer. 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. Giving bortezomib together with thalidomide and dexamethasone may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide and dexamethasone works in treating patients with relapsed or refractory multiple myeloma.

Detailed Description

OBJECTIVES:

• Determine the confirmed overall response rate (complete remission, remission, and partial remission) in patients with relapsed or refractory multiple myeloma treated with bortezomib, thalidomide, and dexamethasone.
• Determine overall and progression-free survival of patients treated with this regimen.
• Determine the qualitative and quantitative toxic effects of this regimen in these patients.
• Correlate, preliminarily, treatment with bortezomib with the activation of osteoblasts in these patients.

OUTLINE: This is a multicenter study.

• Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral thalidomide once daily on days 1-21, and oral dexamethasone once daily on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days until achievement of confirmed complete remission (CR), remission (R), or partial remission (PR) OR for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients achieving confirmed CR, R, or PR who reach a plateau prior to receiving the maximum 8 courses of induction therapy OR who achieve confirmed CR, R, or PR after receiving the maximum 8 courses of induction therapy proceed to maintenance therapy. Patients achieving stable disease after receiving the maximum 8 courses of induction therapy either proceed to maintenance therapy or receive further treatment with bortezomib, thalidomide, and dexamethasone off-study.

• Maintenance therapy: Patients receive oral dexamethasone on days 1-4. Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed within 30 days and then every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bortezomib with thalidomide and dexamethasone

bortezomib with thalidomide and dexamethasone

Group Type: EXPERIMENTAL

bortezomib

Intervention Type: DRUG

induction: 1 mg/m2 IV push days 1, 4, 8, 11 every 21 days

dexamethasone

Intervention Type: DRUG

induction: 20 mg/d PO days 1, 2, 4, 5, 8, 9, 11, 12 every 21 days maintenance: 40 mg days 1-4 every 28 days until progression

thalidomide

Intervention Type: DRUG

100 mg/d PO days 1-21 every 21 days

Interventions

bortezomib

induction: 1 mg/m2 IV push days 1, 4, 8, 11 every 21 days

Intervention Type: DRUG

dexamethasone

induction: 20 mg/d PO days 1, 2, 4, 5, 8, 9, 11, 12 every 21 days maintenance: 40 mg days 1-4 every 28 days until progression

Intervention Type: DRUG

thalidomide

100 mg/d PO days 1-21 every 21 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma (MM)

• Active disease
• Relapsed or refractory disease after ≥ 1 prior therapy for MM, that may have included autologous or allogeneic stem cell transplantation

• Relapse is defined as the occurrence of any of the following during or after prior treatment:

• Myeloma protein level increase by > 100% from the lowest previously recorded level
• Myeloma protein level increase above the defined response criteria for partial remission
• Reappearance of any myeloma peak that had disappeared during the prior treatment
• Increase in the size and number of lytic bone lesions and/or focal lesions by x-ray, MRI, positron emission tomography, and/or CT scan
• Refractory disease is defined as no response (i.e., not achieving complete remission, remission, or partial remission) to prior therapy
• Measurable disease
• No evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of M-protein, and skin changes) syndrome
• Must be registered on protocol SWOG-S0334

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-2 (unless due to bone pain)

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3
• Platelet count > 50,000/mm^3

Hepatic

• AST or ALT ≤ 3 times upper limit of normal (ULN)
• Bilirubin ≤ 3 times ULN

Renal

• Creatinine clearance > 30 mL/min

Cardiovascular

• No New York Heart Association class III or IV congestive heart failure
• No myocardial infarction within the past 6 months
• No poorly controlled hypertension

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile female patients must use effective double method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for 4 weeks after completion of study treatment for male patients)
• No blood, ova, or sperm donation during study treatment
• No active infection requiring antibiotics
• No neurotoxicity ≥ grade 2
• No diabetes mellitus
• No other serious medical or psychiatric illness that would preclude study treatment
• No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• At least 14 days since prior chemotherapy (28 days for nitrosoureas) and recovered

Endocrine therapy

• Not specified

Radiotherapy

• At least 14 days since prior radiotherapy and recovered

Surgery

• Not specified

Other

• No prior bortezomib alone or combined with thalidomide
• Concurrent participation on protocol SWOG-S0309 allowed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gordan Srkalovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sparrow Regional Cancer Center

Mohamad A. Hussein, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Hematology Oncology Consultants - Naperville

Naperville, Illinois, United States

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, United States

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, United States

Genesis Medical Center - West Campus

Davenport, Iowa, United States

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, United States

Wesley Medical Center

Wichita, Kansas, United States

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, United States

Mecosta County Medical Center

Big Rapids, Michigan, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, United States

Spectrum Health Hospital - Butterworth Campus

Grand Rapids, Michigan, United States

Metro Health Hospital

Grand Rapids, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, United States

Holland Community Hospital

Holland, Michigan, United States

Foote Hospital

Jackson, Michigan, United States

Sparrow Regional Cancer Center

Lansing, Michigan, United States

Hackley Hospital

Muskegon, Michigan, United States

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States

Seton Cancer Institute - Saginaw

Saginaw, Michigan, United States

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

St. John Macomb Hospital

Warren, Michigan, United States

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Cape Girardeau, Missouri, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

St. John's Regional Health Center

Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, United States

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, United States

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

St. Vincent Healthcare Cancer Care Services

Billings, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Billings Clinic - Downtown

Billings, Montana, United States

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

St. James Healthcare Cancer Care

Butte, Montana, United States

Big Sky Oncology

Great Falls, Montana, United States

Great Falls Clinic - Main Facility

Great Falls, Montana, United States

Sletten Regional Cancer Institute at Benefis Healthcare

Great Falls, Montana, United States

Great Falls, Montana, United States

St. Peter's Hospital

Helena, Montana, United States

Glacier Oncology, PLLC

Kalispell, Montana, United States

Kalispell Medical Oncology at KRMC

Kalispell, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, United States

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, United States

Tucker Center for Cancer Care at Orange Regional Medical Center

Middletown, New York, United States

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Rutherford Hospital

Rutherfordton, North Carolina, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Grandview Hospital

Dayton, Ohio, United States

Good Samaritan Hospital

Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, United States

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, United States

CCOP - Dayton

Dayton, Ohio, United States

Blanchard Valley Medical Associates

Findlay, Ohio, United States

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, United States

Charles F. Kettering Memorial Hospital

Kettering, Ohio, United States

Middletown Regional Hospital

Middletown, Ohio, United States

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, United States

Cleveland Clinic - Wooster

Wooster, Ohio, United States

United States Air Force Medical Center - Wright-Patterson

Wright-Patterson Air Force Base, Ohio, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, United States

Tod Children's Hospital

Youngstown, Ohio, United States

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Providence Milwaukie Hospital

Milwaukie, Oregon, United States

Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

Portland, Oregon, United States

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, United States

CCOP - Columbia River Oncology Program

Portland, Oregon, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, United States

Legacy Meridian Park Hospital

Tualatin, Oregon, United States

AnMed Cancer Center

Anderson, South Carolina, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Center for Cancer Medicine and Blood Disorders, PA

El Paso, Texas, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Baylor University Medical Center - Houston

Houston, Texas, United States

Ben Taub General Hospital

Houston, Texas, United States

Methodist Hospital

Houston, Texas, United States

St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital

Houston, Texas, United States

Veterans Affairs Medical Center - Houston

Houston, Texas, United States

Wilford Hall Medical Center

Lackland Air Force Base, Texas, United States

CCOP - Scott and White Hospital

Temple, Texas, United States

American Fork Hospital

American Fork, Utah, United States

Sandra L. Maxwell Cancer Center

Cedar City, Utah, United States

Logan Regional Hospital

Logan, Utah, United States

Cottonwood Hospital Medical Center

Murray, Utah, United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, United States

McKay-Dee Hospital Center

Ogden, Utah, United States

Utah Valley Regional Medical Center - Provo

Provo, Utah, United States

Latter Day Saints Hospital

Salt Lake City, Utah, United States

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, United States

Dixie Regional Medical Center - East Campus

St. George, Utah, United States

Danville Regional Medical Center

Danville, Virginia, United States

Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

Martinsville, Virginia, United States

St. Joseph Cancer Center

Bellingham, Washington, United States

Olympic Hematology and Oncology

Bremerton, Washington, United States

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Harborview Medical Center

Seattle, Washington, United States

Minor and James Medical, PLLC

Seattle, Washington, United States

Group Health Central Hospital

Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

Polyclinic First Hill

Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, United States

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, United States

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, United States

Countries

United States

Other Identifiers

S0417

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S0417

Identifier Type: -

Identifier Source: org_study_id