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Multiple MyelomaPhase 2NCT00040937

S0204 Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Multiple Myeloma

A Phase 2 study testing filgrastim, sargramostim and cyclophosphamide in people with Multiple Myeloma, run by SWOG Cancer Research Network at 141 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Myeloma
What is being tested?
filgrastim, sargramostim and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
141 sitesUnited States
Study dates
Jun 2002to Oct 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Newly diagnosed multiple myeloma requiring treatment
  • Smoldering myeloma with evidence of progressive disease requiring chemotherapy
  • More than 25% increase in M component levels and/or Bence-Jones excretion or symptom development
  • Non-secretory patients with at least 30% bone marrow plasmacytosis
  • No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or more than 3 lytic lesions

PATIENT CHARACTERISTICS:

Age

  • 18 to 65

Performance status

  • Zubrod 0-2 OR
  • Zubrod 3-4 based solely on bone pain

Life expectancy

  • Not specified

Hematopoietic

  • No untreated, unresolved symptomatic hyperviscosity

Hepatic

  • Hepatitis B negative

Renal

  • Creatinine no greater than 3 mg/dL if in renal failure and on dialysis (after hydration and/or correction of hypercalcemia)

Cardiovascular

  • No history of chronic cerebrovascular accident
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No congestive heart failure that is difficult to control
  • No uncontrollable hypertension
  • No cardiac arrhythmia that is difficult to control

Pulmonary

  • No history of chronic obstructive or chronic restrictive pulmonary disease
  • No untreated, unresolved pneumonia
  • Pulmonary function tests (PFTs) at least 50% of predicted
  • DLCO at least 50% of predicted
  • Arterial partial pressure of oxygen greater than 70 if unable to complete PFTs due to bone pain or fracture

Other

  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No untreated, unresolved pathologic fractures
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use at least 2 highly effective methods of contraception for 4 weeks before, during, and for at least 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No more than 8 weeks of prior thalidomide therapy

Chemotherapy

  • No prior chemotherapy for this disease

Endocrine therapy

  • Prior steroid therapy allowed provided treatment duration was no more than 2 weeks

Radiotherapy

  • No prior radiotherapy to more than 50% of the pelvis

Surgery

  • Not specified

Trial locations and contacts

141 sites in 1 country.

141 sites in 1 country

United States141 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • Auburn Regional Center for Cancer Care

    Auburn, Washington, 98002

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • Mecosta County General Hospital

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Deaconess Billings Clinic Cancer Center

    Billings, Montana, 59107

  • St. Luke's Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Internal Medicine Associates of Bozeman

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Community Hospital

    Butte, Montana, 59701

  • Regional Cancer Center at Providence Hospital

    Centralia, Washington, 98531

  • Adena Regional Medical Center

    Chillicothe, Ohio, 54601

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Riverside Cancer Services

    Columbus, Ohio, 43215

  • Mount Carmel West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • University of California Davis Cancer Center

    Davis, California, 95616

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Legacy Mount Hood Medical Center

    Glesham, Oregon, 97030

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Mercy Medical Center

    Grand Rapids, Michigan, 49503

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metropolitan Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • Greenville Hospital System Cancer Center

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Cancer Research Center of Hawaii

    Honolula, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • St. Francis Medical Center

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • UMC Southwest Cancer and Research Center

    Lubbock, Texas, 79415

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Eastern Montana Cancer Center

    Miles City, Montana, 59301

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Community Medical Center

    Missoula, Montana, 59801

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

    Missoula, Montana, 59802

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59802

  • Judy L. Schmidt, MD, FACP, P. C.

    Missoula, Montana, 59804

  • Louisiana State University Health Sciences Center - Monroe

    Monroe, Louisiana, 71210

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Hackley Hospital

    Muskegon, Michigan, 49443

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Providence St. Peter Hospital Regional Cancer Center

    Olympia, Washington, 95806

  • Capital Medical Center

    Olympia, Washington, 98507

  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26101

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Institute of Oncology at Vilnius University

    Portland, Oregon, 97227

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • Southern Regional Medical Center

    Riverdale, Georgia, 30274

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Sutter Cancer Center

    Sacramento, California, 95816

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98114

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana, 71130

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29304

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Mercy Medical Center Oncology Unit

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Allenmore Hospital

    Tacoma, Washington, 98405

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • St. Joseph Medical Center at Franciscan Health System

    Tacoma, Washington, 98405

  • St. Clare Hospital

    Tacoma, Washington, 98499

  • Stormont-Vail Cancer Center

    Topeka, Kansas, 66604

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Central Washington Hospital

    Wenatchee, Washington, 98801

  • Wenatchee Valley Clinic

    Wenatchee, Washington, 98801

  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

    Westerville, Ohio, 43081

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157

  • United States Air Force Medical Center Wright-Patterson

    Wright-Patterson AFB, Ohio, 45433-5529

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)

RATIONALE: Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving thalidomide before and after peripheral stem cell transplant may be effective in treating newly diagnosed multiple myeloma.

PURPOSE: This phase II trial is studying how well giving thalidomide with chemotherapy and peripheral stem cell transplant work in treating patients with newly diagnosed multiple myeloma.

Read the detailed description

OBJECTIVES:

  • Determine the efficacy and toxicity of thalidomide and dexamethasone as a pre-transplantation induction regimen in patients with multiple myeloma.
  • Determine, preliminarily, the safety and efficacy of prednisone and thalidomide maintenance therapy in these patients.
  • Correlate chromosome 13 abnormalities with therapeutic response in patients treated with this regimen.
  • Correlate specific subsets of chromosome aberrations with event-free and overall survival of patients treated with this regimen.
  • Evaluate immune reconstitution and recovery after first and second transplantation in these patients.

OUTLINE: This is a multicenter study.

  • Induction chemotherapy: Patients receive oral thalidomide once daily on days 1-35 and oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Treatment repeats every 35 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Stem cell mobilization and collection: Beginning 5-7 days, but no more than 3 weeks, after completion of induction chemotherapy, patients receive cyclophosphamide IV over 45-60 minutes on day 0, filgrastim (G-CSF) subcutaneously (SC) on days 1-10, and sargramostim (GM-CSF) SC beginning on day 1 and continuing until completion of peripheral blood stem cell (PBSC) collection. Patients begin PBSC collection on day 11 or as soon as blood counts recover.
  • First transplantation: Within 3-6 weeks after cyclophosphamide administration, patients receive melphalan IV over 20 minutes on day -1. Patients undergo PBSC infusion on day 0. Patients receive GM-CSF SC or IV beginning on day 6 and continuing until blood counts recover.
  • Second transplantation: Between 2-4 months after first transplantation, patients undergo a second tandem melphalan and PBSC transplantation with GM-CSF support as above.
  • Maintenance therapy: Beginning 70-90 days post-transplantation, patients receive oral prednisone every other day and oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 12 months for 10 years.

PROJECTED ACCRUAL: Approximately 99 patients will be accrued for this study within 18 months.

Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • filgrastimBiological

    Also called G-CSF

    PBSC collection: 10 mcg/kg SQ days 1-10

  • sargramostimBiological

    Also called GM-CSF

    PBSC collection: 500 mcg/m2 SQ day 1 through last apheresis

    1st and 2nd trans: 500 mcg SC or IV days 6-WBC recovery

  • cyclophosphamideDrug

    Also called cytoxan

    PBSC collection: 1 mg/m2 IV over 45-60 mins day 0

  • dexamethasoneDrug

    Also called decadron

    40 mg/d PO days 1-4, 9-12, 17-20

  • melphalanDrug

    1. st trans: 140 mg/m2 IV over 20 mins day -1
    2. nd trans: 200mg/m2 IV over 20 mins day -1

  • prednisoneDrug

    Also called steroid

    maint: 50 mg/d PO every other day until progression

  • thalidomideDrug

    Also called thalomid

    ind: 50 mg increased by 50 mg every week to max 400 mg PO qhs for 35 days maint: 50 mg/d increased by 50 mg every week to 200 mg PO daily until progression

  • peripheral blood stem cell transplantationProcedure or surgery

    Also called stem cell transplant

    2-4 x 10^6/kg IV day 0

Study groups in NCT00040937
Study groupRoleWhat they receive
treatment armExperimentalthalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
Receives: Biological: filgrastim; Biological: sargramostim; Drug: cyclophosphamide; Drug: dexamethasone; Drug: melphalan; Drug: prednisone; Drug: thalidomide; Procedure: peripheral blood stem cell transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: 4-7 years

Secondary outcomes (1)

  1. Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.

    To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.

    Measured: Induction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2002
  3. Primary completionOct 2008
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00040937
Sponsor's protocol ID
S0204
Other IDs
S0204, U10CA032102
Status last verified
Oct 2016
First submitted
8 Jul 2002
Last updated
8 Dec 2016
Data monitoring committee
Yes

Publications

  • Hussein MA, Bolejack V, Zonder JA, Durie BG, Jakubowiak AJ, Crowley JJ, Barlogie B. Phase II study of thalidomide plus dexamethasone induction followed by tandem melphalan-based autotransplantation and thalidomide-plus-prednisone maintenance for untreated multiple myeloma: a southwest oncology group trial (S0204). J Clin Oncol. 2009 Jul 20;27(21):3510-7. doi: 10.1200/JCO.2008.19.9240. Epub 2009 Jun 22.

    PubMed 19546405

  • Hussein MA, Jakubowiak AJ, Bolejack V, et al.: S0204: melphalan (MEL)-based tandem autotransplants (TAT) for multiple myeloma (MM) with thalidomide/dexamethasone (TD) induction and thalidomide/prednisone (TP) maintenance: a phase II trial of the Southwest Oncology Group. [Abstract] Blood 108 (11): A-3088, 2006.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, sargramostim and cyclophosphamide in people with Multiple Myeloma, run by SWOG Cancer Research Network at 141 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 4-7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00040937, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.

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