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

Alternate Title

High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	NCI	SWOG-S0115 S0115, NCT00064337

Objectives

1. Determine overall survival of patients with high-risk multiple myeloma, primary systemic amyloidosis, or light chain deposition disease treated with two courses of modified high-dose melphalan and autologous peripheral blood stem cell transplantation.
2. Determine the hematologic response in patients treated with this regimen.
3. Determine the qualitative and quantitative toxic effects of this regimen in these patients.
4. Determine the prognostic significance of cytogenetic markers in these patients.

Entry Criteria

Disease Characteristics:

• At least 1 of the following diagnoses:
  • Multiple myeloma
    • Stage II or III disease
    • At least 1 of the following must be present:
      • Serum M-protein of IgG, IgA, IgD, IgE greater than 1.0 g/dL
      • Urinary M-protein (Bence-Jones) at least 200 mg/24 hours
    • No IgM peaks except in patients who have physiologic criteria to support a diagnosis of multiple myeloma (e.g., bony lesions, myeloma kidney-cast nephropathy, absence of adenopathy [unless pathology-proven to be plasma cell infiltration])
    • No monoclonal gammopathy of undetermined significance
    • No indolent or smoldering myeloma
    • No disease progression on prior thalidomide or dexamethasone
  • Histologically confirmed primary systemic amyloidosis
    • No senile, secondary, localized, dialysis-related, or familial amyloidosis
    • No severe cardiac involvement
      • No pre-exertional syncope, ventricular arrhythmia, or symptomatic pleural effusions associated with cardiac involvement
  • Light Chain Deposition Disease alone or in combination with multiple myeloma meeting the following criteria:
    • Deposition of granular material containing free light chains/immunoglobulins that did not bind Congo red
    • Evidence of plasma cell dyscrasia (i.e., monoclonal gammopathy in the serum or urine by immunofixation electrophoresis and/or clonal plasmacytosis) on bone marrow biopsy by immunohistochemistry and/or elevated serum-free light chain concentration

• Must have been diagnosed within the past year
• Concurrent enrollment in the myeloma repository protocol SWOG-S0309 must be offered

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics
• Prior cumulative melphalan dose no more than 200 mg
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• No concurrent hormonal therapy

Radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• Recovered from prior therapy
• Prior or concurrent bisphosphonates allowed

Patient Characteristics:

Age

• 18 and over (patients with amyloidosis only OR patients with amyloidosis and multiple myeloma OR patients with multiple myeloma only with poor renal function)

  OR

• 70 and over (patients with multiple myeloma only with or without poor renal function)

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 2.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2.5 times ULN

Renal

• No hemodialysis within 2 hours of melphalan or stem cell infusion

Cardiovascular

• See Disease Characteristics
• Hemodynamically stable (i.e., systolic blood pressure > 90 mm Hg in a lying position within the past 42 days)
• No myocardial infarction within the past 6 months
• No congestive heart failure
• No arrhythmia refractory to medical therapy
• LVEF greater than 45% by echocardiogram or MUGA

Pulmonary

• See Disease Characteristics
• No history of chronic obstructive or chronic restrictive pulmonary disease
• Pulmonary function studies (e.g., FEV₁ and FVC) at least 50% of predicted
• DLCO at least 50% of predicted
• Normal high resolution CT scan of the chest and acceptable arterial blood gases (i.e., PO₂ greater than 70) required for patients unable to complete pulmonary function tests due to bone pain or fracture

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
  • Multiple myeloma patients receiving thalidomide must use 2 methods of effective contraception for at least 4 weeks before, during, and for at least 4 weeks after discontinuation of thalidomide
• HIV negative
• No other concurrent significant medical condition
• No concurrent uncontrolled life-threatening infection
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

Expected Enrollment

A total of 100 patients will be accrued for this study within 20-25 months.

Outcomes

Overall survival

Hematologic response
Qualitative and quantitative toxicity
Prognostic significance of cytogenetic markers

Outline

This is a multicenter study. Patients are stratified according to disease (high-risk multiple myeloma vs primary systemic amyloidosis vs both).

• Induction therapy (multiple myeloma patients only): Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral thalidomide daily on days 1-35. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity.
• Mobilization and stem cell collection:
  • Multiple myeloma patients: Within 28-35 days after completion of induction therapy, patients receive cyclophosphamide IV over 2-3 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 2 and continuing through the day before the last leukapheresis. Usage of mesna IV on day 1 (prior to and twice after cyclophosphamide administration is recommended).
  • Primary systemic amyloidosis patients: Patients receive G-CSF SC daily beginning on day 1 and continuing through the day before the last leukapheresis.

  All patients undergo leukapheresis for the collection of stem cells until the target number of CD34+ cells is reached.

• Conditioning regimen: Within 1-4 weeks after mobilization, patients receive modified high-dose melphalan IV over 20 minutes on day -2.
• Peripheral blood stem cell (PBSC) reinfusion: PBSCs are reinfused on day 0. Patients receive G-CSF SC daily beginning on day 1 and continuing until blood counts recover.

Patients undergo a second autologous PBSC transplantation within 3-6 months, but no later than 12 months, after the first transplantation.

• Second conditioning regimen: Patients receive modified high-dose melphalan IV over 20 minutes on day -2.
• Second PBSC infusion: PBSCs are infused on day 0.
• Maintenance regimen (multiple myeloma patients only): Between 4-8 weeks after the second transplantation, patients with no progressive disease receive oral dexamethasone once daily on days 1-4 and oral thalidomide once daily on days 1-28. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 and 6 months and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Vaishali Sanchorawala, MD, Study coordinator		Ph: 617-638-8261 Email: vaishali.sanchorawala@bmc.org
David Seldin, MD, PhD, Study coordinator		Ph: 617-638-8265

U.S.A.
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Berkeley
	Alta Bates Summit Comprehensive Cancer Center
		Clinical Trials Office - Alta Bates Summit Comprehensive Cancer Center	Ph:  510-204-3428
	Burlingame
	Peninsula Medical Center
		David Irwin, MD	Ph:  510-204-1591
	Greenbrae
	Marin Cancer Institute at Marin General Hospital
		David Irwin, MD	Ph:  510-204-1591
	Sutter Health - Western Division Cancer Research Group
		David Irwin, MD	Ph:  510-204-1591
	La Jolla
	Scripps Cancer Center - San Diego
		James Mason, MD	Ph:  858-554-8597
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	San Francisco
	California Pacific Medical Center - California Campus
		David Irwin, MD	Ph:  510-204-1591
	Vallejo
	Sutter Solano Medical Center
		David Irwin, MD	Ph:  510-204-1591
Idaho
	Boise
	Mountain States Tumor Institute at St. Luke's Regional Medical Center
		William Kreisle, MD	Ph:  208-381-2711
Kansas
	Salina
	Tammy Walker Cancer Center at Salina Regional Health Center
		William Cathcart-Rake, MD	Ph:  785-452-4860
	Wichita
	Wesley Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Louisiana
	Alexandria
	Tulane Cancer Center Office of Clinical Research
		Clinical Trials Office - Tulane Cancer Center	Ph:  504-988-6121
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Center	Ph:  617-353-7571
Michigan
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Josephine Ford Cancer Center at Henry Ford Hospital
		Robert Chapman, MD	Ph:  313-916-1332
Missouri
	Saint Louis
	Saint Louis University Cancer Center
		Clinical Trials Office - Saint Louis University Cancer Center	Ph:  314-977-4440
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
		Benjamin Marchello, MD	Ph:  406-238-6290
	Big Sky Oncology
		Clinical Trail Office - Big Sky Oncology	Ph:  406-731-8217
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sletten Cancer Institute at Benefis Healthcare
		Grant Harrer, MD, FACP, CCTI	Ph:  406-731-8100
	Havre
	Northern Montana Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-238-6290
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
New York
	Rochester
	James P. Wilmot Cancer Center at University of Rochester Medical Center
		Richard Fisher, MD	Ph:  585-275-0842
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
Oregon
	Gresham
	Legacy Mount Hood Medical Center
		Clinical Trials Office - Legacy Mount Hood Medical Center	Ph:  503-413-2150
	Milwaukie
	Providence Milwaukie Hospital
		Keith Lanier, MD	Ph:  503-299-6500
	Portland
	Adventist Medical Center
		Keith Lanier, MD	Ph:  503-299-6500
	CCOP - Columbia River Oncology Program
		Keith Lanier, MD	Ph:  503-299-6500
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University	Ph:  503-494-1080
			Email: trials@ohsu.edu
	Legacy Emanuel Hospital and Health Center and Children's Hospital
		Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital	Ph:  503-413-8199
	Legacy Good Samaritan Hospital & Comprehensive Cancer Center
		Clinical Trials Office - Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Ph:  503-413-1742
	Northwest Cancer Specialists at Rose Quarter Cancer Center
		Kasra Karamlou	Ph:  503-228-6509
	Providence Cancer Center at Providence Portland Medical Center
		Clinical Trials Office - Providence Cancer Center at Providence Portland Medical Center	Ph:  503-215-6412
	Providence St. Vincent Medical Center
		Clinical Trials Office - Providence St. Vincent Medical Center	Ph:  503-215-6412
	Tualatin
	Legacy Meridian Park Hospital
		Clinical Trials Office - Legacy Meridian Park Hospital	Ph:  503-413-1742
Tennessee
	Knoxville
	Thompson Cancer Survival Center
		Clinical Trials Office - Thompson Cancer Survival Center	Ph:  865-541-1812
Washington
	Bellingham
	St. Joseph Cancer Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Bremerton
	Olympic Hematology and Oncology
		Saul Rivkin, MD	Ph:  206-386-2441
	Kennewick
	Columbia Basin Hematology
		Saul Rivkin, MD	Ph:  206-386-2441
	Seattle
	Fred Hutchinson Cancer Research Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Group Health Central Hospital
		Clinical Trials Office - Group Health Central Hospital	Ph:  206-287-2900
	Harborview Medical Center
		Saul Rivkin, MD	Ph:  206-386-2441
	Minor and James Medical, PLLC
		Saul Rivkin, MD	Ph:  206-386-2441
	Polyclinic First Hill
		Saul Rivkin, MD	Ph:  206-386-2441
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Saul Rivkin, MD	Ph:  206-386-2441
	University Cancer Center at University of Washington Medical Center
		Clinical Trials Office - University Cancer Center at University of Washington Medical Center	Ph:  206-616-8289
	Spokane
	Cancer Care Northwest - Spokane South
		Clinical Trials Office - Cancer Care Northwest - Spokane South	Ph:  509-228-1083
	Vancouver
	Legacy Salmon Creek Medical Center
		Kasra Karamlou	Ph:  360-487-1000
	Southwest Washington Medical Center Cancer Center
		Keith Lanier, MD	Ph:  503-299-6500
West Virginia
	Parkersburg
	Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
		Clinical Trials Office - Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital	Ph:  304-424-2585
Wyoming
	Casper
	Rocky Mountain Oncology
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290

Registry Information
Official Title		A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m2) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study)
Trial Start Date		2004-01-01
Trial Completion Date		2014-07-01 (estimated)
Registered in ClinicalTrials.gov		NCT00064337
Date Submitted to PDQ		2003-06-03
Information Last Verified		2009-11-06
NCI Grant/Contract Number		CA32102

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