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Clinical Trials (PDQ®)

An Expanded Access Program For Lenalidomide Plus Dexamethasone In Previously Treated Subjects With Multiple Myeloma

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVTreatmentActive18 and overPharmaceutical / IndustryCC-5013-MM-016
FHCRC-2068.00, CELGENE-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

Prologue Research International, Incorporated

Trial Sites

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, MDPrincipal 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, mDPrincipal 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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
 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal Investigator
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Stefano Tarantolo, MD Ph: 402-354-8124
  Email: drtarantolo@onchemwest.com
 Stefano Tarantolo, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal Investigator
  New York
 Beth Israel Comprehensive Cancer Center - West Side Campus
 Sundar Jagannath, Dr. Ph: 212-604-6068
  Email: sjaganna@salick.com
 Sundar Jagannath, Dr.Principal Investigator
 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
  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, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal 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, MDPrincipal Investigator
  Columbia
 South Carolina Oncology Associates, PA
 Mary Audrey Ackerman Ph: 803-461-3000
 Mary Audrey AckermanPrincipal Investigator
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Kelly McCaul, Dr. Ph: 605-322-3086
  Email: kelly.mccaul@averacancer.org
 Kelly McCaul, Dr.Principal Investigator
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, MDPrincipal 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 GlennPrincipal 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, MDPrincipal Investigator
Wisconsin
  LaCrosse
 Gundersen Lutheran Center for Cancer and Blood
 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
 Oncology Alliance, SC - Milwaukee - South
 Ajit Divgi, Dr.
  Email: adivgi@oncologyallinace.com
 Ajit B. Divgi, Dr.Principal Investigator
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, MDPrincipal 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, MDPrincipal 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

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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