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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
Phase | Type | Status | Age | Protocol IDs |
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Phase IV | Treatment | Active | 18 and over | 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
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U.S.A. |
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Arizona |
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Scottsdale |
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| | | | | | | Mayo Clinic Scottsdale |
| | Craig Reeder, Dr. |
Ph: 480-301-4473 |
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Email:
reeder.craig@mayo.edu |
| | Craig B. Reeder, Dr. | Principal Investigator |
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California |
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Berkeley |
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| | | Alta Bates Summit Comprehensive Cancer Center |
| | David Irwin, Dr. |
Ph: 510-204-1591 |
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Email:
dirwin@salick.com |
| | David H. Irwin, Dr. | Principal Investigator |
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La Jolla |
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| | Ida M. and Cecil H. Green Cancer Center at Scripps Clinic |
| | Richard Just, Dr. |
Ph: 858-882-8301 |
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Email:
just.richard@scrippshealth.org |
| | Richard G. Just, Dr. | Principal Investigator |
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Los Angeles |
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| | Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center |
| | Robert Vescio, Dr. |
Ph: 310-423-1825 |
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Email:
robert.vescio@cshs.org |
| | Robert Vescio, MD | Principal Investigator |
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San Diego |
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| | Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego |
| | Jonathan Polikoff, Dr. |
Ph: 619-528-5170 |
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Email:
jonathan.a.polikoff@kp.org |
| | Jonathan A. Polikoff, Dr. | Principal Investigator |
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Stanford |
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| | Stanford Cancer Center |
| | Steven Coutre, Dr. |
Ph: 650-725-4040 |
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Email:
coutre@stanford.edu |
| | Steven E. Coutre, Dr. | Principal Investigator |
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Vallejo |
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| | Kaiser Permanente Medical Center - Vallejo |
| | Louis Fehrenbacher, MD |
Ph: 707-651-2797 |
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Email:
lou.fehrenbacher@kp.org |
| | Desiree Goldstein |
Ph: 707-651-2797 |
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Email:
desiree.goldstein@kp.org |
| | Louis Fehrenbacher, mD | Principal Investigator |
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Colorado |
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Aurora |
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| | | University of Colorado Cancer Center at UC Health Sciences Center |
| | Brian Abbott, Dr. |
Ph: 720-848-0300 |
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Email:
brian.abbott@uchsc.edu |
| | Brian Abbott, Dr. | Principal Investigator |
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Denver |
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| | Rocky Mountain Cancer Centers - Denver Midtown |
| | Jeff Matous, Dr. |
Ph: 303-285-5000 |
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Email:
jeffrey.matous@usoncology.com |
| | Jeffrey V. Matous, Dr. | Principal Investigator |
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Connecticut |
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New Haven |
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| | | Yale Cancer Center |
| | Stuart Seropian, Dr. |
Ph: 203-737-5751 |
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Email:
stuart.seropian@yale.edu |
| | Stuart Seropian, Dr. | Principal Investigator |
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Stamford |
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| | Hematology Oncology, PC at Bennett Cancer Center |
| | Michael Bar, MD |
Ph: 203-323-8944 |
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Email:
hoa_researchig@yahoo.com |
| | Michael H. Bar, MD | Principal Investigator |
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Florida |
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Miami |
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| | | University of Miami Sylvester Comprehensive Cancer Center - Miami |
| | Kelvin Lee, MD |
Ph: 305-243-1044 |
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Email:
klee@med.miami.edu |
| | Kelvin Lee, MD | Principal Investigator |
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St. Petersburg |
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| | Gulfcoast Oncology Associates - 5th Avenue |
| | Joseph Mace, MD |
Ph: 727-821-0017 |
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Email:
jmace@gulfcoastoncology.com |
| | Margie Blazek |
Ph: 727-821-0017 |
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Email:
mblazek@gulfcoastoncology.com |
| | Joseph Mace, MD | Principal Investigator |
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Tampa |
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| | H. Lee Moffitt Cancer Center and Research Institute at University of South Florida |
| | Melissa Alsina, Dr. |
Ph: 813-979-7202 |
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Email:
alsinam@moffitt.usf.edu |
| | Melissa Alsina, Dr. | Principal Investigator |
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West Palm Beach |
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| | Palm Beach Cancer Institute - West Palm Beach |
| | Daniel Spitz, MD |
Ph: 561-366-4128 |
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Email:
daniel.spitz@pbcancer.com |
| | Daniel Spitz, MD | Principal Investigator |
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Georgia |
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Atlanta |
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| | | Winship Cancer Institute of Emory University |
| | Sagar Lonial, Dr. |
Ph: 404-727-5572 |
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Email:
sloni01@emory.edu |
| | Sagar Lonial, Dr. | Principal Investigator |
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Illinois |
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Chicago |
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| | | Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
| | Seema Singhal, Dr. |
Ph: 312-695-6180 |
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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 |
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Email:
stephanie_gregory@rush.edu |
| | Stephanie Ann Gregory, Dr. | Principal Investigator |
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Indiana |
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Indianapolis |
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| | | Indiana University Melvin and Bren Simon Cancer Center |
| | Rafat Abonour, Dr. |
Ph: 317-278-1810 |
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Email:
rabonour@iupui.edu |
| | Rafat Abonour, MD | Principal Investigator |
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Kansas |
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Kansas City |
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| | | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center |
| | Delva Deauna-Limayo, Dr. |
Ph: 913-588-6077 |
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Email:
ddeauna@kumc.edu |
| | Delva Deauna-Limayo, Dr. | Principal Investigator |
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Wichita |
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| | CCOP - Wichita |
| | David B. Johnson, Dr. |
Ph: 316-268-5696 |
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Email:
marge_good@via-christi.org |
| | David B. Johnson, Dr. | Principal Investigator |
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Louisiana |
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New Orleans |
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| | | Ochsner Cancer Institute at Ochsner Clinic Foundation |
| | Archie Brown, MD |
Ph: 504-842-3708 |
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Email:
abrown@ochsner.org |
| | Kate Rodger |
Ph: 504-842-3708 |
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Email:
krodger@ochsner.org |
| | Archie Brown, MD | Principal Investigator |
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Maine |
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Scarborough |
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| | | Maine Center for Cancer Medicine and Blood Disorders - Scarborough |
| | Jacquelyn Hedlund, MD |
Ph: 207-885-7634 |
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Email:
chasee@mccm.org |
| | Jacquelyn Hedlund, MD | Principal Investigator |
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Maryland |
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Baltimore |
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| | | Greenebaum Cancer Center at University of Maryland Medical Center |
| | Ashraf Badros, Dr. |
Ph: 410-328-1230 |
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Email:
abadros@umm.edu |
| | Ashraf Z. Badros, Dr. | Principal Investigator |
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Bethesda |
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| | Center for Cancer and Blood Disorders |
| | Ralph V Boccia, Dr. |
Ph: 301-571-0019 |
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Email:
rboccia@ccbdmd.com |
| | Ralph Vincent Boccia, Dr. | Principal Investigator |
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Massachusetts |
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Boston |
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| | | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
| | Paul Richardson, Dr. |
Ph: 617-632-2104 |
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Email:
paul_richardson@dfci.harvard.edu |
| | Paul Gerard Guy Richardson, Dr. | Principal Investigator |
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Minnesota |
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Rochester |
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| | | Mayo Clinic Cancer Center |
| | Shaji K. Kumar, MD |
Ph: 507-284-2511 |
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Email:
kumar.shaji@mayo.edu |
| | Shaji K. Kumar, MD | Principal Investigator |
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Missouri |
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St. Louis |
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| | | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
| | Ravi Vij, Dr. |
Ph: 314-454-8304 |
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Email:
rvij@im.wustl.edu |
| | Ravi Vij, MD | Principal Investigator |
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Montana |
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Billings |
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| | | Billings Clinic Cancer Center |
| | Roger Santala, MD |
Ph: 406-238-2844 |
| | Kathy Wilkinson |
Ph: 406-238-2866 |
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Email:
kwilkinson@billingsclinic.org |
| | Roger Santala, MD | Principal Investigator |
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Nebraska |
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Omaha |
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| | | Methodist Estabrook Cancer Center |
| | Stefano Tarantolo, MD |
Ph: 402-354-8124 |
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Email:
drtarantolo@onchemwest.com |
| | Stefano Tarantolo, MD | Principal Investigator |
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Nevada |
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Las Vegas |
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| | | Nevada Cancer Center - Central |
| | Ann Wierman, Dr. |
Ph: 702-735-7154 |
| | Ann Wierman, Dr. | Principal Investigator |
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New Hampshire |
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Lebanon |
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| | | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center |
| | Kenneth Meehan, MD |
Ph: 603-650-4628 |
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Email:
kenneth.meehan@hitchcock.org |
| | Kenneth Meehan, MD | Principal Investigator |
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New Jersey |
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Hackensack |
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| | | Hackensack University Medical Center Cancer Center |
| | David Siegel, Dr. |
Ph: 201-336-8020 |
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Email:
dsiegel@humed.com |
| | David Samuel Siegel, Dr. | Principal Investigator |
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New York |
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Bronx |
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| | | MBCCOP - Our Lady of Mercy Comprehensive Cancer Center |
| | Peter Wiernik, Dr. |
Ph: 718-920-1100 |
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Email:
pwiernik@olmhs.org |
| | Peter H. Wiernik, Dr. | Principal Investigator |
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Brooklyn |
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| | SUNY Downstate Medical Center |
| | Olcay Batuman, MD |
Ph: 718-270-2785 |
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Email:
obatuman@downstate.edu |
| | Nikita Watson |
Ph: 718-270-2931 |
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Email:
nikita.watson@downstate.edu |
| | Olcay Batuman, MD | Principal Investigator |
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East Setauket |
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| | North Shore Hematology/Oncology Associates, PC |
| | Edward Samuel, MD |
Ph: 631-751-3000 |
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Email:
sgoldberg@nshoa.com |
| | Sharon Goldberg |
Ph: 631-751-3000 |
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Email:
sgoldberg@nshoa.com |
| | Edward Samuel, MD | Principal Investigator |
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New York |
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| | New York Weill Cornell Cancer Center at Cornell University |
| | Ruben Niesvizky, Dr. |
Ph: 212-746-3964 |
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Email:
run9001@med.cornell.edu |
| | Ruben Niesvizky, Dr. | Principal Investigator |
| | St. Vincent's Comprehensive Cancer Center - Manhattan |
| | Sundar Jagannath, Dr. |
Ph: 212-604-6068 |
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Email:
sjaganna@salick.com |
| | Sundar Jagannath, Dr. | Principal Investigator |
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Syracuse |
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| | SUNY Upstate Medical University Hospital |
| | Teresa Gentile, Dr. |
Ph: 315-464-8240 |
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Email:
gentilet@upstate.edu |
| | Teresa C. Gentile, Dr. | Principal Investigator |
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North Carolina |
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Charlotte |
|
| | | Carolinas Hematology-Oncology Associates |
| | Steven Limentani, Dr. |
Ph: 704-446-9046 |
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Email:
slimentani@carolinas.org |
| | Steven A. Limentani, MD | Principal Investigator |
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Winston-Salem |
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| | Wake Forest University Comprehensive Cancer Center |
| | David Hurd, Dr. |
Ph: 336-713-7972 |
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Email:
dhurd@wfubmc.edu |
| | David Duane Hurd, Dr. | Principal Investigator |
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North Dakota |
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Fargo |
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| | | Dakota Cancer Institute at Dakota Clinic - South University |
| | Kaushik Sen, Dr. |
Ph: 701-364-8910 |
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Email:
ksen@dakcl.com |
| | Kaushik Sen, Dr. | Principal Investigator |
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Ohio |
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Columbus |
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| | | Mid Ohio Oncology & Hematology, Inc. |
| | Timothy Moore, MD |
Ph: 614-469-2660 Ext.7151 |
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Email:
tmoore@mooh.com |
| | Timohty Moore, MD | Principal Investigator |
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Oregon |
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Portland |
|
| | | Kaiser Permanente Medical Office - Interstate Medical Office Central |
| | Negandra Tirumali, Dr. |
Ph: 503-331-6500 |
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Email:
nagendra.tirumali@kp.org |
| | Nagendra Tirumali, MD | Principal Investigator |
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Pennsylvania |
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Philadelphia |
|
| | | Abramson Cancer Center of the University of Pennsylvania |
| | Edward Stadtmauer, Dr. |
Ph: 215-662-7910 |
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Email:
edward.stadtmauer@uphs.upenn.edu |
| | Edward Allen Stadtmauer, Dr. | Principal Investigator |
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Pittsburgh |
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| | UPMC Cancer Centers |
| | G. David Roodman, Dr. |
Ph: 412-688-6571 |
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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 |
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Email:
rshadduck@msn.com |
| | Richard K Shadduck, MD | Principal Investigator |
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South Carolina |
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Charleston |
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| | | 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 |
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Email:
stuartrk@musc.edu |
| | Robert Kenneth Stuart, MD | Principal Investigator |
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Columbia |
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| | South Carolina Oncology Associates, PA |
| | Mary Audrey Ackerman |
Ph: 803-461-3000 |
| | Mary Audrey Ackerman | Principal Investigator |
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South Dakota |
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Sioux Falls |
|
| | | Avera Cancer Institute |
| | Kelly McCaul, Dr. |
Ph: 605-322-3086 |
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Email:
kelly.mccaul@averacancer.org |
| | Kelly McCaul, Dr. | Principal Investigator |
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Texas |
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Dallas |
|
| | | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas |
| | Vikas Bhushan, Dr. |
Ph: 214-648-1852 |
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Email:
vikas.bhushan@utshouthwestern.com |
| | Vikas Bhushan, MD | Principal Investigator |
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Houston |
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| | M. D. Anderson Cancer Center at University of Texas |
| | Donna Weber, Dr. |
Ph: 713-792-2850 |
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Email:
dmweber@mdanderson.org |
| | Donna Weber, Dr. | Principal Investigator |
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Utah |
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Salt Lake City |
|
| | | Huntsman Cancer Institute at University of Utah |
| | Martha Glenn |
Ph: 801-585-0236 |
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Email:
martha.glenn@hci.utah.edu |
| | Martha Glenn | Principal Investigator |
| | LDS Hospital |
| | W. Graydon Harker, Dr. |
Ph: 801-269-0231 |
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Email:
gharker@utahcancer.com |
| | W. Graydon Harker, Dr. | Principal Investigator |
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Washington |
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Seattle |
|
| | | Fred Hutchinson Cancer Research Center |
| | Leona Holmberg, Dr. |
Ph: 206-667-4832 |
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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 |
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Email:
Hank.Kaplan@swedish.org |
| | Dione Pedersen |
Ph: 206-386-2444 |
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Email:
dione.pedersen@swedish.org |
| | Henry G. Kaplan, MD | Principal Investigator |
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Wisconsin |
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LaCrosse |
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| | | Gundersen Lutheran Center for Cancer and Blood |
| | Craig Cole, Dr. |
Ph: 608-782-7300 |
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Email:
cecole@gundluth.org |
| | Craig Cole, Dr. | Principal Investigator |
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Marshfield |
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| | Marshfield Clinic - Marshfield Center |
| | Matthias Weiss, Dr. |
Ph: 715-389-3531 |
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Email:
weigel.lori@mcrf.mfldclin.edu |
| | Matthias Weiss, Dr. | Principal Investigator |
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Milwaukee |
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| | Oncology Alliance, SC - Milwaukee - South |
| | Ajit Divgi, Dr. | |
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Email:
adivgi@oncologyallinace.com |
| | Ajit B. Divgi, Dr. | Principal Investigator |
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Canada |
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Alberta |
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Calgary |
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| | | | Tom Baker Cancer Centre - Calgary |
| | Nizar Bahlis, Dr. |
Ph: 403-944-1564 |
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Email:
nbahlis@ucalgary.ca |
| | Nizar Bahlis, Dr. | Principal Investigator |
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Edmonton |
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| | Cross Cancer Institute at University of Alberta |
| | Tony Reiman, MD |
Ph: 780-432-8757 |
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Email:
tonyreim@cacnerboard.ab.ca |
| | Joanne Hewitt |
Ph: 780-432-8791 |
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Email:
joannehe@cancerboard.ab.ca |
| | Anthony J. Reiman, MD | Principal Investigator |
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British Columbia |
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Vancouver |
|
| | | Vancouver General Hospital |
| | Kevin Song, Dr. |
Ph: 608-875-4863 |
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Email:
ksong@bccancer.bc.ca |
| | Kevin Song, Dr. | Principal Investigator |
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Nova Scotia |
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Halifax |
|
| | | Nova Scotia Cancer Centre |
| | Darrell White, MD |
Ph: 902-473-4642 |
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Email:
Susan.Pleasance@cdha.nshealth.ca |
| | Susan Pleasance |
Ph: 902-473-7585 |
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Email:
Susan.Pleasance@cdha.nshealth.ca |
| | Darrell White, Dr. | Principal Investigator |
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Ontario |
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Toronto |
|
| | | Princess Margaret Hospital |
| | Donna Reece, MD |
Ph: 416-946-2824 |
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Email:
donna.reece@uhn.on.ca |
| | Esther Masih-Khan, PhD |
Ph: 416-946-4576 |
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Email:
esther.masih-khan@uhn.on.ca |
| | Donna Reece, MD | Principal Investigator |
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Quebec |
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Montreal |
|
| | | McGill Cancer Centre at McGill University |
| | Chaim Shustik, Dr. |
Ph: 514-842-1231, ext. 31558 |
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Email:
ShustikC@muhchem.mcgill.ca |
| | Chaim Shustik, Dr. | Principal Investigator |
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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. Back to Top |
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