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NCT00040937

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

Last Updated: 2016-12-08

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma

Keywords

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stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment arm

thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

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

sargramostim

Intervention Type BIOLOGICAL

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

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

cyclophosphamide

Intervention Type DRUG

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

dexamethasone

Intervention Type DRUG

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

melphalan

Intervention Type DRUG

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

prednisone

Intervention Type DRUG

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

thalidomide

Intervention Type DRUG

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 transplantation

Intervention Type PROCEDURE

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

Interventions

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filgrastim

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

Intervention Type BIOLOGICAL

sargramostim

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

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

Intervention Type BIOLOGICAL

cyclophosphamide

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

Intervention Type DRUG

dexamethasone

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

Intervention Type DRUG

melphalan

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

Intervention Type DRUG

prednisone

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

Intervention Type DRUG

thalidomide

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

Intervention Type DRUG

peripheral blood stem cell transplantation

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

Intervention Type PROCEDURE

Other Intervention Names

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G-CSF GM-CSF cytoxan decadron steroid thalomid stem cell transplant

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamad A. Hussein, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

University of California Davis Cancer Center

Davis, California, United States

Site Status

Sutter Roseville Medical Center

Roseville, California, United States

Site Status

Sutter Cancer Center

Sacramento, California, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

CCOP - Atlanta Regional

Atlanta, Georgia, United States

Site Status

Northside Hospital Cancer Center

Atlanta, Georgia, United States

Site Status

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Site Status

WellStar Cobb Hospital

Austell, Georgia, United States

Site Status

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, United States

Site Status

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Site Status

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, United States

Site Status

Southern Regional Medical Center

Riverdale, Georgia, United States

Site Status

Cancer Research Center of Hawaii

Honolula, Hawaii, United States

Site Status

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, United States

Site Status

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, United States

Site Status

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, United States

Site Status

St. Francis Medical Center

Honolulu, Hawaii, United States

Site Status

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, United States

Site Status

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, United States

Site Status

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Site Status

St. Francis Hospital and Health Centers

Beech Grove, Indiana, United States

Site Status

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

Kansas City, Kansas, United States

Site Status

Salina Regional Health Center

Salina, Kansas, United States

Site Status

Stormont-Vail Cancer Center

Topeka, Kansas, United States

Site Status

St. Francis Comprehensive Cancer Center

Topeka, Kansas, United States

Site Status

Wesley Medical Center

Wichita, Kansas, United States

Site Status

Louisiana State University Health Sciences Center - Monroe

Monroe, Louisiana, United States

Site Status

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, United States

Site Status

Bay Regional Medical Center

Bay City, Michigan, United States

Site Status

Mecosta County General Hospital

Big Rapids, Michigan, United States

Site Status

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

Site Status

Lacks Cancer Center at Saint Mary's Mercy Medical Center

Grand Rapids, Michigan, United States

Site Status

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, United States

Site Status

Metropolitan Hospital

Grand Rapids, Michigan, United States

Site Status

Holland Community Hospital

Holland, Michigan, United States

Site Status

Hackley Hospital

Muskegon, Michigan, United States

Site Status

Northern Michigan Hospital

Petoskey, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status