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

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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, 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

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

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, 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: 614-469-2660Ext. 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

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, 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 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, 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 Identifier 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.