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

Alternate Title

Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI SWOG-S0777 S0777, NCT00644228

Special Category: CTSU trial

Objectives

Primary

1. To compare progression-free survival of patients with newly diagnosed multiple myeloma treated with lenalidomide and low-dose dexamethasone with or without bortezomib.

Secondary

1. To assess response using the new international response criteria.
2. To assess overall survival and other long-term outcomes stratified by intent to undergo transplantation at progression.
3. To verify the reported benefit of bortezomib in promoting bone repair/healing by comparing and contrasting the bone healing as determined by achievement of MRI-CR.
4. To utilize MRI for accurate baseline staging plus evaluation of response and progression.
5. To compare achievement of MRI-CR with achievement of x-ray-CR.

Entry Criteria

Disease Characteristics:

• Newly diagnosed multiple myeloma (MM)
  • Stage I, II, or III disease by the New International Staging System



• Measurable disease



• Nonsecretory MM based upon standard M-component criteria (i.e., measurable serum/urine M-component) is not allowed unless the baseline serum free light chain level (Freelite™) is elevated



• Must be offered participation in the Myeloma Specimen Repository for banking and future research



• Institutions must submit a local cytogenetics report and FISH analysis prior to study entry

Prior/Concurrent Therapy:

• No prior chemotherapy for this disease
• No prior radiotherapy to a large area of the pelvis (i.e., more than half of the pelvis)
• No prior bortezomib or lenalidomide
• Prior steroid treatment allowed provided treatment was no more than 2 weeks in duration
• Must be able to take concurrent aspirin 325 mg daily (or enoxaparin 40 mg subcutaneously daily if allergic to aspirin) as prophylactic coagulation

Patient Characteristics:

• Zubrod performance status 0-3
• Platelet count ≥ 80,000/mm³*
• ANC ≥ 1,000/mm³*
• Hemoglobin ≥ 9.0 g/dL* (including patients who have been transfused or treated with epoetin)
• Creatinine clearance > 30 cc/min
• FEV₁ and FVC ≥ 50% of predicted**
• DLCO ≥ 50% of predicted**
• No uncontrolled, active infection requiring IV antibiotics
• No NYHA class III-IV heart failure
• No myocardial infarction within the past 6 months
• No history of treatment for clinically significant ventricular cardiac arrythmias
• No poorly controlled hypertension
• No poorly controlled diabetes mellitus
• No chronic obstructive or chronic restrictive pulmonary disease
• Must have undergone an EKG within the past month
• No psychiatric illness that could potentially interfere with the completion of study treatment
• No history of cerebral vascular accident with persistent neurologic deficits
• No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
• No hepatitis B or C positivity
• HIV negative***
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment
  • Female patients must use 2 reliable forms of contraception simultaneously
  • Male patients must use effective barrier contraception
• Patients with pathologic fractures, pneumonia at diagnosis, or symptomatic hyperviscosity syndrome must have these conditions attended to prior to study entry (i.e., intramedullary rod, IV antibiotics, or plasmapheresis)

 [Note: *Except patients with biopsy-proven heavy-marrow involvement, defined as having ≥ 30% marrow cellularity with 50% of the cells being malignant plasma cells (documented marrow results required)]

 [Note: **Patients who are unable to complete pulmonary function tests due to bone pain or fracture must undergo high resolution CT scan of the chest and have acceptable arterial blood gases, defined as P0₂ > 70; these tests must be completed within 42 days prior to study entry]

 [Note: ***Patients with treatment-sensitive HIV infection are eligible provided immunological and virologic indices are indicative of favorable long-term survival prospects on the basis of HIV infection, but whose life expectancy is limited predominantly by multiple myeloma rather than HIV infection in the judgement of the treating physician]

Expected Enrollment

Outcomes

Progression-free survival

Response rates
Overall survival

Outline

Patients are stratified according to the International Staging System (I vs II vs III) and intent to undergo transplantation at relapse (yes vs no).

• Induction therapy: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive oral dexamethasone once daily on days 1, 8, 15, and 22 and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral dexamethasone once daily on days 1, 2, 4, 5, 8, 9, 11, and 12; oral lenalidomide once daily on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

  In both arms, patients who intend to undergo transplantation at relapse undergo peripheral blood stem cell collection after course 2.




• Maintenance therapy: After the completion of 6 months of induction therapy, patients receive maintenance therapy comprising oral dexamethasone once daily on days 1, 8, 15, and 22 and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 6 years.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Brian Durie, MD, Protocol chair		Ph: 323-966-3572 Email: bdurie@aptiumoncology.com
Bart Barlogie, MD, Protocol co-chair		Ph: 501-526-2873

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
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Burlingame
	Peninsula Medical Center
		David Irwin, MD	Ph:  510-204-2866
	Fullerton
	Virginia K. Crosson Cancer Center at St. Jude Medical Center
		Clinical Trials Office - Virginia K. Crosson Cancer Center	Ph:  714-446-5642
	Greenbrae
	Marin Cancer Institute at Marin General Hospital
		David Irwin, MD	Ph:  510-204-2866
	Sutter Health - Western Division Cancer Research Group
		David Irwin, MD	Ph:  510-204-2866
	Palm Springs
	Desert Regional Medical Center Comprehensive Cancer Center
		Clinical Trials Office - Desert Regional Medical Center Comprehensive Cancer Center	Ph:  760-416-4730
	San Francisco
	California Pacific Medical Center - California Campus
		David Irwin, MD	Ph:  510-204-2866
	Vallejo
	Sutter Solano Medical Center
		David Irwin, MD	Ph:  510-204-2866
Colorado
	Fort Collins
	Poudre Valley Hospital
		Clinical Trials Office - Poudre Valley Hospital	Ph:  970-495-8226
Connecticut
	Norwalk
	Norwalk Hospital
		Richard Frank, MD	Ph:  203-855-3517
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Orlando
	Florida Hospital Cancer Institute at Florida Hospital Orlando
		Clinical Trials Office - Florida Hospital Cancer Institute	Ph:  407-303-5623
	Stuart
	Robert and Carol Weissman Cancer Center at Martin Memorial
		Guillermo Abesada-Terk, MD	Ph:  772-223-5952
		Guillermo Abesada-Terk, MD	Ph:  772-223-5952
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Aurora
	Rush-Copley Cancer Care Center
		Kendrith Rowland, MD	Ph:  217-383-3010
	Bloomington
	St. Joseph Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Canton
	Graham Hospital
		John Kugler, MD	Ph:  309-243-3000
	Carthage
	Memorial Hospital
		John Kugler, MD	Ph:  309-243-3000
	Eureka
	Eureka Community Hospital
		John Kugler, MD	Ph:  309-243-3000
	Galesburg
	Galesburg Clinic, PC
		John Kugler, MD	Ph:  309-243-3000
	Galesburg Cottage Hospital
		John Kugler, MD	Ph:  309-243-3000
	Havana
	Mason District Hospital
		John Kugler, MD	Ph:  309-243-3000
	Hopedale
	Hopedale Medical Complex
		John Kugler, MD	Ph:  309-243-3000
	Joliet
	Joliet Oncology-Hematology Associates, Limited - West
		Kendrith Rowland, MD	Ph:  217-383-3010
	Macomb
	McDonough District Hospital
		John Kugler, MD	Ph:  309-243-3000
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Normal
	BroMenn Regional Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Community Cancer Center
		John Kugler, MD	Ph:  309-243-3000
	Ottawa
	Community Hospital of Ottawa
		John Kugler, MD	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Ottawa
		John Kugler, MD	Ph:  309-243-3000
	Pekin
	Cancer Treatment Center at Pekin Hospital
		John Kugler, MD	Ph:  309-243-3000
	Peoria
	CCOP - Illinois Oncology Research Association
		John Kugler, MD	Ph:  309-243-3000
	Methodist Medical Center of Illinois
		Clinical Trials Office - Methodist Medical Center of Illinois	Ph:  309-243-3000
	Oncology Hematology Associates of Central Illinois, PC - Peoria
		John Kugler, MD	Ph:  309-243-3000
	OSF St. Francis Medical Center
		John Kugler, MD	Ph:  309-243-3000
	Proctor Hospital
		John Kugler, MD	Ph:  309-243-3000
	Peru
	Illinois Valley Community Hospital
		John Kugler, MD	Ph:  309-243-3000
	Princeton
	Perry Memorial Hospital
		John Kugler, MD	Ph:  309-243-3000
	Spring Valley
	St. Margaret's Hospital
		John Kugler, MD	Ph:  309-243-3000
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
	Urbana
	Carle Cancer Center at Carle Foundation Hospital
		Clinical Trials Office - Carle Cancer Center	Ph:  800-446-5532
	CCOP - Carle Cancer Center
		Clinical Trials Office - CCOP - Carle Cancer Center	Ph:  800-446-5532
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  317-787-3311
	Fort Wayne
	Fort Wayne Medical Oncology and Hematology
		Sreenivasa Nattam, MD	Ph:  260-484-8830 800-852-2333
	Michigan City
	Saint Anthony Memorial Health Centers
		Kendrith Rowland, MD	Ph:  217-383-3010
	Munster
	Community Hospital
		Erwin Robin, MD	Ph:  219-836-4503
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  765-983-3000
Iowa
	Cedar Rapids
	Cedar Rapids Oncology Associates
		Clinical Trials Office - Cedar Rapids Oncology Associates	Ph:  319-363-2690
	Ottumwa
	McCreery Cancer Center at Ottumwa Regional
		Roscoe Morton, MD, FACP	Ph:  515-244-7586
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-9326
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-9326
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-9326
Kansas
	Salina
	Tammy Walker Cancer Center at Salina Regional Health Center
		William Cathcart-Rake, MD	Ph:  785-827-7261
	Topeka
	Cotton-O'Neil Cancer Center
		Clinical Trials Office - Cotton-O'Neil Cancer Center	Ph:  785-270-4963
	Wichita
	Wesley Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Center	Ph:  617-353-7571
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  877-590-5995
	Saint Joseph Mercy Cancer Center
		Philip Stella, MD	Ph:  734-712-5658 888-474-4673
	Battle Creek
	Battle Creek Health System Cancer Care Center
		Marianne Lange, MD	Ph:  616-966-8000
	Big Rapids
	Mecosta County Medical Center
		Marianne Lange, MD	Ph:  231-796-8691
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center	Ph:  313-593-8090
	Detroit
	Barbara Ann Karmanos Cancer Institute
		Clinical Trials Office - Barbara Ann Karmanos Cancer Institute	Ph:  313-576-9363
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Thomas Saphner, MD, FACP	Ph:  800-432-6049
	Flint
	Genesys Hurley Cancer Institute
		Clinical Trials Office - Genesys Hurley Cancer Institute	Ph:  810-762-8057
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grand Rapids
	Butterworth Hospital at Spectrum Health
		Marianne Lange, MD	Ph:  616-391-2799
	CCOP - Grand Rapids
		Marianne Lange, MD	Ph:  616-391-1230
	Lacks Cancer Center at Saint Mary's Health Care
		Marianne Lange, MD	Ph:  616-752-5222
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Holland
	Holland Community Hospital
		Marianne Lange, MD	Ph:  616-392-5141
	Iron Mountain
	Dickinson County Healthcare System
		Thomas Saphner, MD, FACP	Ph:  906-774-1313
	Jackson
	Foote Memorial Hospital
		Philip Stella, MD	Ph:  517-788-4800
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7488
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7488
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Lansing
	Sparrow Regional Cancer Center
		Clinical Trials Office - Sparrow Regional Cancer Center	Ph:  517-364-2890
	Livonia
	St. Mary Mercy Hospital
		Philip Stella, MD	Ph:  734-464-4800
	Mount Clemens
	Ted B. Wahby Cancer Center at Mount Clemens General Hospital
		Clinical Trials Office - Ted B. Wahby Cancer Center at Mount Clemens General Hospital	Ph:  586-493-3426
	Muskegon
	Hackley Hospital
		Marianne Lange, MD	Ph:  231-726-3511
	Pontiac
	St. Joseph Mercy Oakland
		Philip Stella, MD	Ph:  248-858-3612
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip Stella, MD	Ph:  810-985-1484
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph:  989-776-8411
	Traverse City
	Munson Medical Center
		Marianne Lange, MD	Ph:  231-935-6202
	Warren
	St. John Macomb Hospital
		Philip Stella, MD	Ph:  586-573-5757 888-593-2237
	Wyoming
	Metro Health Hospital
		Marianne Lange, MD	Ph:  616-252-7200
Minnesota
	Burnsville
	Fairview Ridges Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Maplewood
	Minnesota Oncology Hematology, PA - Maplewood
		Patrick Flynn, MD	Ph:  612-863-8585
	Minneapolis
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  612-863-8585
	Park Nicollet Cancer Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Saint Paul
	United Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Waconia
	Ridgeview Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Woodbury
	Minnesota Oncology Hematology, PA - Woodbury
		Patrick Flynn, MD	Ph:  612-863-8585
Missouri
	Cape Girardeau
	Saint Francis Medical Center
		Bethany Sleckman, MD	Ph:  314-251-6573
	Gape Girardeau
	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
		Bethany Sleckman, MD	Ph:  314-251-6573
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany Sleckman, MD	Ph:  314-251-6573
	David C. Pratt Cancer Center at St. John's Mercy
		Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy	Ph:  314-251-6770
	Midwest Hematology Oncology Group, Incorporated
		Bethany Sleckman, MD	Ph:  314-251-6573
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:  406-259-2245 800-361-3239
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290 800-648-6274
	Northern Rockies Radiation Oncology Center
		Benjamin Marchello, MD	Ph:  406-248-2212 800-358-8818
	St. Vincent Healthcare Cancer Care Services
		Benjamin Marchello, MD	Ph:  406-657-7000
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-585-5070
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-723-2500
	Great Falls
		Benjamin Marchello, MD
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-454-2171 800-421-1649
	Havre
	Northern Montana Hospital
		Benjamin Marchello, MD	Ph:  406-265-2211 800-352-5097
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-442-2480
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-752-7600
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-752-8900
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-752-5111
	Missoula
	Community Medical Center
		Benjamin Marchello, MD	Ph:  406-728-4100
	Guardian Oncology and Center for Wellness
		Benjamin Marchello, MD	Ph:  406-721-1118
	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
	Glens Falls
	Adirondack Cancer Care - Glens Falls
		Mark Hoffman, MD	Ph:  518-761-0000
	Middletown
	Tucker Center for Cancer Care at Orange Regional Medical Center
		Clinical Trials Office - Tucker Center for Cancer Care at Orange Regional Medical Center	Ph:  845-342-7609
North Carolina
	Goldsboro
	Wayne Memorial Hospital, Incorporated
		James Atkins, MD	Ph:  919-580-0000
	Hendersonville
	Pardee Memorial Hospital
		James Radford, MD	Ph:  828-692-8045
	Kinston
	Kinston Medical Specialists
		Peter Watson, MD	Ph:  252-559-2200 ext. 201
	Rutherfordton
	Rutherford Hospital
		James Bearden, MD	Ph:  864-560-6812
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
Ohio
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-395-8678
	Good Samaritan Hospital
		Howard Gross, MD	Ph:  937-278-2612
	Grandview Hospital
		Howard Gross, MD	Ph:  937-226-3200
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-279-5800 800-616-6784
	Veterans Affairs Medical Center - Dayton
		Howard Gross, MD	Ph:  937-268-6511
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  419-424-0380
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  513-424-2111
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospital	Ph:  937-298-3399 ext. 57556
	Lima
	St. Rita's Medical Center
		Clinical Trials Office - St. Rita's Medical Center	Ph:  419-226-9617
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center	Ph:  937-440-4842
	Wilmington
	Clinton Memorial Hospital
		Howard Gross, MD	Ph:  937-382-6611
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-352-2140
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:  503-513-8300
	Portland
	Adventist Medical Center
		Keith Lanier, MD	Ph:  503-257-2500
	CCOP - Columbia River Oncology Program
		Keith Lanier, MD	Ph:  503-216-6260
	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
	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
Pennsylvania
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Hazleton
	Geisinger Hazleton Cancer Center
		Adel Makary, MD	Ph:  570-271-6045
	Lancaster
	Lancaster General Hospital
		Randall Oyer	Ph:  717-544-5511
	Philadelphia
	Joan Karnell Cancer Center at Pennsylvania Hospital
		Bernard Mason, MD	Ph:  215-829-6088
	State College
	Geisinger Medical Group - Scenery Park
		Adel Makary, MD	Ph:  570-271-6045
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Ph:  570-271-5251
	Mercy Hospital at Wilkes-Barre
		Adel Makary, MD	Ph:  570-271-6045
South Carolina
	Anderson
	AnMed Cancer Center
		Clinical Trials Office - AnMed Cancer Center	Ph:  864-512-1000
	Spartanburg
	CCOP - Upstate Carolina
		Clinical Trials Office - CCOP - Upstate Carolina	Ph:  800-486-5941
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Clinical Trials Office - Gibbs Regional Cancer Center	Ph:  800-486-5941
Tennessee
	Kingsport
	Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
		Clinical Trials Office - Christine LaGuardia Phillips Cancer Center	Ph:  423-224-5593
	Memphis
	University of Tennessee Cancer Institute - Memphis
		Clinical Trials Office - University of Tennessee Cancer Institute	Ph:  901-448-3303
Texas
	Fort Sam Houston
	Brooke Army Medical Center
		Clinical Trials Office - Brooke Army Medical Center	Ph:  210-916-4837
	Houston
	Baylor University Medical Center - Houston
		Martha Mims	Ph:  713-798-8070
	Ben Taub General Hospital
		Martha Mims	Ph:  713-873-2000
	Methodist Hospital
		Martha Mims	Ph:  713-441-1010
	St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
		Martha Mims	Ph:  832-355-3490
	Veterans Affairs Medical Center - Houston
		Martha Mims	Ph:  713-794-7111 800-553-2278
	Lackland AFB
	Wilford Hall Medical Center
		Douglas Nelson, MD	Ph:  228-377-6588
Virginia
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753
	Martinsville
	Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
		Arthur Sleeper, MD	Ph:  276-666-7827
	Norton
	Southwest Virginia Regional Cancer Center at Wellmonth Health
		Malcolm Mathews, MD	Ph:  423-224-3150
Washington
	Vancouver
	Southwest Washington Medical Center Cancer Center
		Keith Lanier, MD	Ph:  360-514-2174
Wisconsin
	Eau Claire
	Marshfield Clinic Cancer Care at Regional Cancer Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Thomas Saphner, MD, FACP	Ph:  920-884-3135
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Thomas Saphner, MD, FACP	Ph:  920-432-6049
	St. Mary's Hospital Medical Center - Green Bay
		Thomas Saphner, MD, FACP	Ph:  920-498-4200
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	La Crosse
	Franciscan Skemp Healthcare - La Crosse Campus
		Haleem Rasool	Ph:  608-785-0940
	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Thomas Saphner, MD, FACP	Ph:  715-735-6523 888-788-2070
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Saint Joseph's Hospital
		Matthias Weiss, MD	Ph:  715-358-1266
	Minocqua
	Marshfield Clinic - Lakeland Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Thomas Saphner, MD, FACP	Ph:  920-846-3444 800-432-6049
	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
	Stevens Point
	Saint Michael's Hospital Cancer Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Thomas Saphner, MD, FACP	Ph:  800-432-6049
	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
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  307-674-6022

Registry Information
Official Title		A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
Trial Start Date		2008-04-01
Trial Completion Date		2011-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00644228
Date Submitted to PDQ		2008-03-17
Information Last Verified		2008-10-16
NCI Grant/Contract Number		CA32102