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

Alternate Title

Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Biomarker/Laboratory analysis, Natural history/Epidemiology, Treatment	Active	18 and over	NCI	ECOG-E1A06 E1A06, NCT00602641

Special Category: CTSU trial

Objectives

Primary

1. To compare progression-free survival between patients receiving melphalan, prednisone, and thalidomide versus melphalan, prednisone, and lenalidomide in newly diagnosed multiple myeloma patients who are not candidates for high-dose therapy.

Secondary

1. To compare overall survival between both arms.
2. To compare response rates and depth of response in these patients.
3. To compare the incidence of toxicities in these patients.
4. To validate the TC classification of myeloma as a prognostic tool using gene expression profiling at diagnosis.

Tertiary

1. To compare quality-of-life (QOL) change between arms based on the FACT-Ntx TOI from baseline to the end of course 24 (maintenance therapy).
2. To examine the impact of differential treatment responses on QOL based on the FACT-Ntx TOI up to course 38.
3. To obtain prospective data on myeloma specific QOL attributes.

Entry Criteria

Disease Characteristics:

• Newly diagnosed multiple myeloma (MM), meeting the following criteria:
  • Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
  • Symptomatic disease with evidence of end-organ damage at initial diagnosis that prompted the initiation of therapy, including ≥ 1 of the following:
    • Anemia
    • Hypercalcemia
    • Bone disease (lytic bone lesions or pathologic fracture)
    • Renal dysfunction
• No smoldering MM, defined by all of the following:
  • Serum monoclonal protein ≥ 3 g/dL
  • Bone marrow plasma cells ≥ 10% or greater
  • Absence of anemia, hypercalcemia, lytic bone lesions, or renal dysfunction
• No monoclonal gammopathy of undetermined significance, defined by all of the following:
  • Serum monoclonal protein < 3 g/dL
  • Bone marrow plasma cells ≤ 10%
  • Absence of anemia, hypercalcemia, lytic bone lesions, or renal dysfunction
• Previously untreated for MM
• Patients 18 to 64 years old must not be a candidate for autologous stem cell transplantation or have declined transplantation or other alternative treatment

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior treatment for myeloma except for either of the following:
  • Prednisone or dexamethasone treatment for myeloma for a duration of less than 4 weeks
  • Prednisone or dexamethasone in combination with thalidomide or lenalidomide for a duration of less than 2 weeks total
• Concurrent bisphosphonates or growth factors (i.e., erythropoietin) for MM allowed
• Concurrent localized radiation therapy is allowed for pain control at the physician’s discretion

Patient Characteristics:

• ECOG performance status 0-2
• Hemoglobin > 7 g/dL
• Platelet count > 75,000/mm³
• ANC > 1,000/mm³
• Creatinine < 2.5 mg/dL
• Direct bilirubin ≤ 1.5 mg/dL
• ALT and AST ≤ 2.5 times upper limit of normal
• No uncontrolled intercurrent illness that would limit compliance with the study including, but not limited to, any of the following:
  • Uncontrolled hypertension
  • Symptomatic congestive heart failure
  • Unstable angina
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled psychiatric illness or social situation
  • Prior history of Stevens Johnson syndrome
• No peripheral neuropathy ≥ grade 2
• No active uncontrolled infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-barrier contraception 4 weeks prior to, during, and 4 weeks after completion of study treatment
• Must be able to take prophylatic aspirin 325mg/day or low-molecular weight heparin or coumadin
• No second active malignancy requiring treatment within the past 2 years, except for basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix

Expected Enrollment

Outcomes

Progression-free survival
Overall survival

Response rates and depth of response comparison
Toxicity
Quality-of-life (QOL) change comparison of arms measured by FACT-Ntx TOI from baseline to course 24
Differential treatment response on QOL measured by FACT-Ntx TOI from baseline to course 38
TC classification validation of myeloma as a prognostic tool using gene expression profiling

Outline

This is a multicenter study. Patients are stratified according to ISS stage (I-II vs III) and age (< 65 vs ≥ 65). Patients are randomized to 1 of 2 treatment arms.

• Arm I:
  • Induction therapy: Patients receive oral melphalan and oral prednisone once daily on days 1-4, and oral thalidomide once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance therapy: Patients receive oral thalidomide once daily and continue in the absence of disease progression.
• Arm II:
  • Induction therapy: Patients receive oral melphalan and oral prednisone once daily on days 1-4, and oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance therapy: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression.

Quality of life is assessed at baseline and periodically during treatment.

Peripheral blood and bone marrow samples are collected at baseline for gene expression profiling analysis.

After completion of study treatment, patients will be followed periodically for 10 years.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

A. Keith Stewart, MD, Protocol chair		Ph: 480-301-4411
S. Rajkumar, MD, Protocol co-chair		Ph: 507-284-8430 Email: rajks@mayo.edu

U.S.A.
California
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	San Diego
	Kaiser Permanente Medical Office -Vandever Medical Office
		Han Koh	Ph:  619-528-2596
Colorado
	Fort Collins
	Front Range Cancer Specialists
		Robert Marschke, Jr.	Ph:  970-212-7600
	Poudre Valley Hospital
		Clinical Trials Office - Poudre Valley Hospital	Ph:  970-495-8226
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center	Ph:  954-776-3239
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Rogerio Lilenbaum, MD	Ph:  305-535-3310
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
	Mason City
	Mercy Cancer Center at Mercy Medical Center - North Iowa
		Clinical Trials Office - Mercy Cancer Center at Mercy Medical Center - North Iowa	Ph:  641-422-6304
	Ottumwa
	McCreery Cancer Center at Ottumwa Regional
		Robert Behrens	Ph:  641-684-2946
	Waterloo
	Covenant Cancer Treatment Center
		Clinical Trials Office - Covenant Cancer Treatment Center	Ph:  319-272-2070
Kansas
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Wesley Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Maine
	Portland
	Mercy Hospital
		Roger Inhorn, MD, PhD	Ph:  207-879-3030
Minnesota
	Bemidji
	MeritCare Bemidji
		Preston Steen, MD	Ph:  701-234-2397
	Duluth
	CCOP - Duluth
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Duluth Clinic Cancer Center - Duluth
		Clinical Trials Office - Duluth Clinic Cancer Center - Duluth	Ph:  218-786-3308
	Miller - Dwan Medical Center
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
Nebraska
	Kearney
	Good Samaritan Cancer Center at Good Samaritan Hospital
		Clinical Trials Office - Good Samaritan Cancer Center at Good Samaritan Hospital	Ph:  308-865-7963
	Omaha
	Alegant Health Cancer Center at Bergan Mercy Medical Center
		Clinical Trials Office - Alegant Health Cancer Center at Bergen Mercy Medical Center	Ph:  402-398-6060
	CCOP - Missouri Valley Cancer Consortium
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
	Creighton University Medical Center
		Clinical Trials Office - Creighton University Medical Center	Ph:  402-280-4100
	Immanuel Medical Center
		Gamini Soori, MD, FACP, FRCP, MBA	Ph:  402-393-3110
	UNMC Eppley Cancer Center at the University of Nebraska Medical Center
		Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Ph:  800-999-5465
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724
North Carolina
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200ext.201
North Dakota
	Bismarck
	Bismarck Cancer Center
		Edward Wos, DO	Ph:  701-323-5741
	Medcenter One Hospital Cancer Care Center
		Edward Wos, DO	Ph:  701-323-5741
	Mid Dakota Clinic, PC
		Clinical Trials Office - Mid Dakota Clinic, PC	Ph:  701-530-6950
	St. Alexius Medical Center Cancer Center
		Clinical Trials Office - St. Alexius Medical Center Cancer Center	Ph:  701-530-6950
	Fargo
	CCOP - MeritCare Hospital
		Preston Steen, MD	Ph:  701-234-2397
	MeritCare Broadway
		Preston Steen, MD	Ph:  701-234-2397
Ohio
	Bellefontaine
	Mary Rutan Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Chillicothe
	Adena Regional Medical Center
		Clinical Trials Office - Adena Regional Medical Center	Ph:  877-779-7585
	Cleveland
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce Averbook, MD, FACS	Ph:  216-778-4795
	Columbus
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Doctors Hospital at Ohio Health
		Clinical Trials Office - Doctors Hospital at Ohio Health	Ph:  614-566-3275
	Grant Medical Center Cancer Care
		Clinical Trials Office - Grant Medical Center Cancer Care	Ph:  614-566-4475
	Mount Carmel Health - West Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Mercy Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Zanesville
	Genesis - Good Samaritan Hospital
		Clinical Trials Office - Genesis - Good Samaritan Hospital	Ph:  740-454-5232
Oklahoma
	Lawton
	Cleo Craig Cancer Research Clinic
		Nadim Nimeh, MD	Ph:  580-536-2121ext.113
Pennsylvania
	Bryn Mawr
	Bryn Mawr Hospital
		Clinical Trials Office - Bryn Mawr Hospital	Ph:  610-645-2680
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu
	Paoli
	Cancer Center of Paoli Memorial Hospital
		Clinical Trials Office - Cancer Center of Paoli Memorial Hospital	Ph:  610-648-1637
	Wynnewood
	CCOP - Main Line Health
		Paul Gilman, MD	Ph:  610-645-2000
	Lankenau Cancer Center at Lankenau Hospital
		Paul Gilman, MD	Ph:  610-645-2000
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  800-811-8480
Texas
	Temple
	CCOP - Scott and White Hospital
		Lucas Wong, MD	Ph:  254-724-1053
Virginia
	Charlottesville
	University of Virginia Cancer Center
		John Densmore, MD	Ph:  434-924-9637
Washington
	Auburn
	Auburn Regional Center for Cancer Care
		Lauren Colman, MD	Ph:  253-403-1677
	Centralia
	Providence Centralia Hospital
		Clinical Trials Office - Providence Centralia Hospital	Ph:  360-493-4300
	Federal Way
	St. Francis Hospital
		Lauren Colman, MD	Ph:  253-403-1677
	Olympia
	Providence St. Peter Hospital Regional Cancer Center
		Lauren Colman, MD	Ph:  253-403-1677
	Puyallup
	Good Samaritan Cancer Center
		Lauren Colman, MD	Ph:  253-403-1677
	Tacoma
	Allenmore Hospital
		Lauren Colman, MD	Ph:  253-403-1677
	CCOP - Northwest
		Lauren Colman, MD	Ph:  253-403-1677
	Franciscan Cancer Center at St. Joseph Medical Center
		Clinical Trials Office - Franciscan Cancer Center	Ph:  253-426-6914
	MultiCare Regional Cancer Center at Tacoma General Hospital
		Clinical Trials Office - MultiCare Regional Cancer Center	Ph:  253-403-3229
	St. Clare Hospital
		Lauren Colman, MD	Ph:  253-403-1677
West Virginia
	Charleston
	West Virginia University Health Sciences Center - Charleston
		Steven Jubelirer, MD	Ph:  304-388-8380
Wisconsin
	Eau Claire
	Marshfield Clinic Cancer Care at Regional Cancer Center
		Matthias Weiss, MD	Ph:  715-358-1266
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Minocqua
	Marshfield Clinic - Lakeland Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Rhinelander
	Ministry Medical Group at Saint Mary's Hospital
		Matthias Weiss, MD	Ph:  715-358-1266
	Rice Lake
	Marshfield Clinic - Indianhead Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Wausau
	University of Wisconcin Cancer Center at Aspirus Wausau Hospital
		Clinical Trials Office - University of Wisconsin Cancer Center	Ph:  608-262-5223
	Weston
	Marshfield Clinic - Weston Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Wisconsin Rapids
	Marshfield Clinic - Wisconsin Rapids Center
		Matthias Weiss, MD	Ph:  715-358-1266

Registry Information
Official Title		An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid™) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy
Trial Start Date		2008-02-29
Trial Completion Date		2009-08-24 (estimated)
Registered in ClinicalTrials.gov		NCT00602641
Date Submitted to PDQ		2008-01-03
Information Last Verified		2009-11-06
NCI Grant/Contract Number		CA21115

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