Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active 18 and over Pharmaceutical / Industry CC-5013-MM-016 NCT00179647

Trial Description

Summary

Subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone in 4 week cycles until disease progression is documented or lenalidomide becomes commercially available for multiple myeloma.

Eligibility Criteria

Inclusion Criteria:

1. Must understand and voluntarily sign an informed consent form.

2. Must be > or = to 18 years of age at the time of signing the informed consent form.

3. Must be able to adhere to the study visit schedule and other protocol requirements.

4. Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment (see Appendix 21.4).

5. Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other eligibility criteria are satisfied.

6. Measurable levels of myeloma paraprotein in serum (>/=0.5 g/dL) or urine (>/=0.2 g excreted in a 24-hour collection sample).

7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (see Appendix 21.3).

8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study medication.

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

2. Pregnant or lactating females.

3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

4. Any of the following laboratory abnormalities:

a. Absolute neutrophil count (ANC) <1,000 cells/mm3 (1.0 x 109/L)

b. Platelet count <75,000/mm3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells.

c. Platelet count <30,000/mm3 (30x109/L) for subjects in whom >/= 50% of bone marrow nucleated cells are plasma cells.

d. Serum creatinine >2.5 mg/dL (221 mmol/L)

e. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)

f. Serum total bilirubin >2.0 mg/dL (34 mmol/L)

5. Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for >/= 1 year.

6. Known hypersensitivity to thalidomide or dexamethasone.

7. Prior history of uncontrollable side effects to dexamethasone therapy.

8. The development of a desquamating rash while taking thalidomide.

9. Use of any standard/experimental anti-myeloma drug therapy within 28 days of the initiation of study drug treatment or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of the initiation of study drug treatment.

Trial Contact Information

Trial Lead Organizations/Sponsors

Celgene Corporation

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Craig Reeder, Dr.	Ph: 480-301-4473
			Email: reeder.craig@mayo.edu
		Craig B. Reeder, Dr.	Principal Investigator
California
	Berkeley
	Alta Bates Summit Comprehensive Cancer Center
		David Irwin, Dr.	Ph: 510-204-1591
			Email: dirwin@salick.com
		David H. Irwin, Dr.	Principal Investigator
	La Jolla
	Ida M. and Cecil H. Green Cancer Center at Scripps Clinic
		Richard Just, Dr.	Ph: 858-882-8301
			Email: just.richard@scrippshealth.org
		Richard G. Just, Dr.	Principal Investigator
	Los Angeles
	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
		Robert Vescio, Dr.	Ph: 310-423-1825
			Email: robert.vescio@cshs.org
		Robert Vescio, MD	Principal Investigator
	San Diego
	Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
		Jonathan Polikoff, Dr.	Ph: 619-528-5170
			Email: jonathan.a.polikoff@kp.org
		Jonathan A. Polikoff, Dr.	Principal Investigator
	Stanford
	Stanford Cancer Center
		Steven Coutre, Dr.	Ph: 650-725-4040
			Email: coutre@stanford.edu
		Steven E. Coutre, Dr.	Principal Investigator
	Vallejo
	Kaiser Permanente Medical Center - Vallejo
		Louis Fehrenbacher, MD	Ph: 707-651-2797
			Email: lou.fehrenbacher@kp.org
		Desiree Goldstein	Ph: 707-651-2797
			Email: desiree.goldstein@kp.org
		Louis Fehrenbacher, mD	Principal Investigator
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Brian Abbott, Dr.	Ph: 720-848-0300
			Email: brian.abbott@uchsc.edu
		Brian Abbott, Dr.	Principal Investigator
	Denver
	Rocky Mountain Cancer Centers - Denver Midtown
		Jeff Matous, Dr.	Ph: 303-285-5000
			Email: jeffrey.matous@usoncology.com
		Jeffrey V. Matous, Dr.	Principal Investigator
Connecticut
	New Haven
	Yale Cancer Center
		Stuart Seropian, Dr.	Ph: 203-737-5751
			Email: stuart.seropian@yale.edu
		Stuart Seropian, Dr.	Principal Investigator
	Stamford
	Hematology Oncology, PC at Bennett Cancer Center
		Michael Bar, MD	Ph: 203-323-8944
			Email: hoa_researchig@yahoo.com
		Michael H. Bar, MD	Principal Investigator
Florida
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		Kelvin Lee, MD	Ph: 305-243-1044
			Email: klee@med.miami.edu
		Kelvin Lee, MD	Principal Investigator
	St. Petersburg
	Gulfcoast Oncology Associates - 5th Avenue
		Joseph Mace, MD	Ph: 727-821-0017
			Email: jmace@gulfcoastoncology.com
		Margie Blazek	Ph: 727-821-0017
			Email: mblazek@gulfcoastoncology.com
		Joseph Mace, MD	Principal Investigator
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Melissa Alsina, Dr.	Ph: 813-979-7202
			Email: alsinam@moffitt.usf.edu
		Melissa Alsina, Dr.	Principal Investigator
	West Palm Beach
	Palm Beach Cancer Institute - West Palm Beach
		Daniel Spitz, MD	Ph: 561-366-4128
			Email: daniel.spitz@pbcancer.com
		Daniel Spitz, MD	Principal Investigator
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Sagar Lonial, Dr.	Ph: 404-727-5572
			Email: sloni01@emory.edu
		Sagar Lonial, Dr.	Principal Investigator
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Seema Singhal, Dr.	Ph: 312-695-6180
			Email: s-singhal@northwestern.edu
		Seema Singhal, MD	Principal Investigator
	Rush Cancer Institute at Rush University Medical Center
		Stephanie A Gregory, Dr.	Ph: 312-942-5982
			Email: stephanie_gregory@rush.edu
		Stephanie Ann Gregory, Dr.	Principal Investigator
Indiana
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Rafat Abonour, Dr.	Ph: 317-278-1810
			Email: rabonour@iupui.edu
		Rafat Abonour, MD	Principal Investigator
Kansas
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Delva Deauna-Limayo, Dr.	Ph: 913-588-6077
			Email: ddeauna@kumc.edu
		Delva Deauna-Limayo, Dr.	Principal Investigator
	Wichita
	CCOP - Wichita
		David B. Johnson, Dr.	Ph: 316-268-5696
			Email: marge_good@via-christi.org
		David B. Johnson, Dr.	Principal Investigator
Louisiana
	New Orleans
	Ochsner Cancer Institute at Ochsner Clinic Foundation
		Archie Brown, MD	Ph: 504-842-3708
			Email: abrown@ochsner.org
		Kate Rodger	Ph: 504-842-3708
			Email: krodger@ochsner.org
		Archie Brown, MD	Principal Investigator
Maine
	Scarborough
	Maine Center for Cancer Medicine and Blood Disorders - Scarborough
		Jacquelyn Hedlund, MD	Ph: 207-885-7634
			Email: chasee@mccm.org
		Jacquelyn Hedlund, MD	Principal Investigator
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Ashraf Badros, Dr.	Ph: 410-328-1230
			Email: abadros@umm.edu
		Ashraf Z. Badros, Dr.	Principal Investigator
	Bethesda
	Center for Cancer and Blood Disorders at Suburban Hospital
		Ralph V Boccia, Dr.	Ph: 301-571-0019
			Email: rboccia@ccbdmd.com
		Ralph Vincent Boccia, Dr.	Principal Investigator
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
		Paul Richardson, Dr.	Ph: 617-632-2104
			Email: paul_richardson@dfci.harvard.edu
		Paul Gerard Guy Richardson, Dr.	Principal Investigator
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Shaji K. Kumar, MD	Ph: 507-284-2511
			Email: kumar.shaji@mayo.edu
		Shaji K. Kumar, MD	Principal Investigator
Missouri
	St. Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Ravi Vij, Dr.	Ph: 314-454-8304
			Email: rvij@im.wustl.edu
		Ravi Vij, MD	Principal Investigator
Montana
	Billings
	Billings Clinic Cancer Center
		Roger Santala, MD	Ph: 406-238-2844
		Kathy Wilkinson	Ph: 406-238-2866
			Email: kwilkinson@billingsclinic.org
		Roger Santala, MD	Principal Investigator
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Stefano Tarantolo, MD	Ph: 402-354-8124
			Email: drtarantolo@onchemwest.com
		Stefano Tarantolo, MD	Principal Investigator
Nevada
	Las Vegas
	Nevada Cancer Center - Central
		Ann Wierman, Dr.	Ph: 702-735-7154
		Ann Wierman, Dr.	Principal Investigator
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Kenneth Meehan, MD	Ph: 603-650-4628
			Email: kenneth.meehan@hitchcock.org
		Kenneth Meehan, MD	Principal Investigator
New Jersey
	Hackensack
	Hackensack University Medical Center Cancer Center
		David Siegel, Dr.	Ph: 201-336-8020
			Email: dsiegel@humed.com
		David Samuel Siegel, Dr.	Principal Investigator
New York
	Bronx
	MBCCOP - Our Lady of Mercy Comprehensive Cancer Center
		Peter Wiernik, Dr.	Ph: 718-920-1100
			Email: pwiernik@olmhs.org
		Peter H. Wiernik, Dr.	Principal Investigator
	Brooklyn
	SUNY Downstate Medical Center
		Olcay Batuman, MD	Ph: 718-270-2785
			Email: obatuman@downstate.edu
		Nikita Watson	Ph: 718-270-2931
			Email: nikita.watson@downstate.edu
		Olcay Batuman, MD	Principal Investigator
	East Setauket
	North Shore Hematology/Oncology Associates, PC
		Edward Samuel, MD	Ph: 631-751-3000
			Email: sgoldberg@nshoa.com
		Sharon Goldberg	Ph: 631-751-3000
			Email: sgoldberg@nshoa.com
		Edward Samuel, MD	Principal Investigator
	New York
	New York Weill Cornell Cancer Center at Cornell University
		Ruben Niesvizky, Dr.	Ph: 212-746-3964
			Email: run9001@med.cornell.edu
		Ruben Niesvizky, Dr.	Principal Investigator
	St. Vincent's Comprehensive Cancer Center - Manhattan
		Sundar Jagannath, Dr.	Ph: 212-604-6068
			Email: sjaganna@salick.com
		Sundar Jagannath, Dr.	Principal Investigator
	Syracuse
	SUNY Upstate Medical University Hospital
		Teresa Gentile, Dr.	Ph: 315-464-8240
			Email: gentilet@upstate.edu
		Teresa C. Gentile, Dr.	Principal Investigator
North Carolina
	Charlotte
	Carolinas Hematology-Oncology Associates
		Steven Limentani, Dr.	Ph: 704-446-9046
			Email: slimentani@carolinas.org
		Steven A. Limentani, MD	Principal Investigator
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		David Hurd, Dr.	Ph: 336-713-7972
			Email: dhurd@wfubmc.edu
		David Duane Hurd, Dr.	Principal Investigator
North Dakota
	Fargo
	Dakota Cancer Institute at Dakota Clinic - South University
		Kaushik Sen, Dr.	Ph: 701-364-8910
			Email: ksen@dakcl.com
		Kaushik Sen, Dr.	Principal Investigator
Ohio
	Columbus
	Mid Ohio Oncology & Hematology, Inc.
		Timothy Moore, MD	Ph: 614-469-2660 Ext.7151
			Email: tmoore@mooh.com
		Timohty Moore, MD	Principal Investigator
Oregon
	Portland
	Kaiser Permanente Medical Office - Interstate Medical Office Central
		Negandra Tirumali, Dr.	Ph: 503-331-6500
			Email: nagendra.tirumali@kp.org
		Nagendra Tirumali, MD	Principal Investigator
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Edward Stadtmauer, Dr.	Ph: 215-662-7910
			Email: edward.stadtmauer@uphs.upenn.edu
		Edward Allen Stadtmauer, Dr.	Principal Investigator
	Pittsburgh
	UPMC Cancer Centers
		G. David Roodman, Dr.	Ph: 412-688-6571
			Email: roodmangd@msx.upmc.edu
		G. David Roodman, Dr.	Principal Investigator
	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
		Richard K Shadduck, MD	Ph: 412-578-4355
			Email: rshadduck@msn.com
		Richard K Shadduck, MD	Principal Investigator
South Carolina
	Charleston
	Charleston Hematology Oncology Associates, PA
		George Geils, MD	Ph: 843-577-6957
		George F. Geils, Dr.	Principal Investigator
	Hollings Cancer Center at Medical University of South Carolina
		Robert Stuart, MD	Ph: 843-792-4271
			Email: stuartrk@musc.edu
		Robert Kenneth Stuart, MD	Principal Investigator
	Columbia
	South Carolina Oncology Associates, PA
		Mary Audrey Ackerman	Ph: 803-461-3000
		Mary Audrey Ackerman	Principal Investigator
South Dakota
	Sioux Falls
		Kelly McCaul, Dr.	Principal Investigator
	Avera Cancer Institute
		Kelly McCaul, Dr.	Ph: 605-322-3086
			Email: kelly.mccaul@averacancer.org
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Vikas Bhushan, Dr.	Ph: 214-648-1852
			Email: vikas.bhushan@utshouthwestern.com
		Vikas Bhushan, MD	Principal Investigator
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Donna Weber, Dr.	Ph: 713-792-2850
			Email: dmweber@mdanderson.org
		Donna Weber, Dr.	Principal Investigator
Utah
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Martha Glenn	Ph: 801-585-0236
			Email: martha.glenn@hci.utah.edu
		Martha Glenn	Principal Investigator
	LDS Hospital
		W. Graydon Harker, Dr.	Ph: 801-269-0231
			Email: gharker@utahcancer.com
		W. Graydon Harker, Dr.	Principal Investigator
Washington
	Seattle
	Fred Hutchinson Cancer Research Center
		Leona Holmberg, Dr.	Ph: 206-667-4832
			Email: iholmber@fhcrc.orf
		Leona A. Holmberg, Dr.	Principal Investigator
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Henry Kaplan, Dr.	Ph: 206-386-2828
			Email: Hank.Kaplan@swedish.org
		Dione Pedersen	Ph: 206-386-2444
			Email: dione.pedersen@swedish.org
		Henry G. Kaplan, MD	Principal Investigator
Wisconsin
	LaCrosse
	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
		Craig Cole, Dr.	Ph: 608-782-7300
			Email: cecole@gundluth.org
		Craig Cole, Dr.	Principal Investigator
	Marshfield
	Marshfield Clinic - Marshfield Center
		Matthias Weiss, Dr.	Ph: 715-389-3531
			Email: weigel.lori@mcrf.mfldclin.edu
		Matthias Weiss, Dr.	Principal Investigator
	Milwaukee
		Ajit B. Divgi, Dr.	Principal Investigator
	Oncology Alliance, SC - Milwaukee - South
		Ajit Divgi, Dr.
			Email: adivgi@oncologyallinace.com
Canada
Alberta
	Calgary
	Tom Baker Cancer Centre - Calgary
		Nizar Bahlis, Dr.	Ph: 403-944-1564
			Email: nbahlis@ucalgary.ca
		Nizar Bahlis, Dr.	Principal Investigator
	Edmonton
	Cross Cancer Institute at University of Alberta
		Tony Reiman, MD	Ph: 780-432-8757
			Email: tonyreim@cacnerboard.ab.ca
		Joanne Hewitt	Ph: 780-432-8791
			Email: joannehe@cancerboard.ab.ca
		Anthony J. Reiman, MD	Principal Investigator
British Columbia
	Vancouver
	Vancouver General Hospital
		Kevin Song, Dr.	Ph: 608-875-4863
			Email: ksong@bccancer.bc.ca
		Kevin Song, Dr.	Principal Investigator
Nova Scotia
	Halifax
	Nova Scotia Cancer Centre
		Darrell White, MD	Ph: 902-473-4642
			Email: Susan.Pleasance@cdha.nshealth.ca
		Susan Pleasance	Ph: 902-473-7585
			Email: Susan.Pleasance@cdha.nshealth.ca
		Darrell White, Dr.	Principal Investigator
Ontario
	Toronto
	Princess Margaret Hospital
		Donna Reece, MD	Ph: 416-946-2824
			Email: donna.reece@uhn.on.ca
		Esther Masih-Khan, PhD	Ph: 416-946-4576
			Email: esther.masih-khan@uhn.on.ca
		Donna Reece, MD	Principal Investigator
Quebec
	Montreal
	McGill Cancer Centre at McGill University
		Chaim Shustik, Dr.	Ph: 514-842-1231, ext. 31558
			Email: ShustikC@muhchem.mcgill.ca
		Chaim Shustik, Dr.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00179647
Information obtained from ClinicalTrials.gov on 2006-05-16