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Doxorubicin |
Adriamycin; Rubex |
Clinical Trial: Bortezomib and Liposomal Doxorubicin in Treating Patients With Multiple Myeloma
This study is currently recruiting patients.
Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining bortezomib with liposomal doxorubicin may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with liposomal doxorubicin works in treating patients with multiple myeloma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma | Drug: bortezomib Drug: pegylated doxorubicin HCl liposome Procedure: chemotherapy Procedure: enzyme inhibitor therapy | Phase II |
MedlinePlus related topics: Multiple Myeloma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Bortezomib and Pegylated Doxorubicin HCl Liposome in Patients With Symptomatic Multiple Myeloma
Further Study Details:
OBJECTIVES: Primary
- Determine complete response (CR) and near-complete response (nCR) rates in patients with previously untreated, symptomatic multiple myeloma treated with bortezomib and pegylated doxorubicin HCl liposome.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine the overall response rate, including CR, nCR, and partial response (PR), in patients treated with this regimen.
- Determine the impact of this regimen on the ability to collect peripheral blood stem cells in patients undergoing subsequent autologous stem cell transplantation.
- Determine time to progression in patients treated with this regimen.
- Determine the value of early change in levels of serum interleukin-6 and macrophage inflammatory protein 1 alfa as predictors of response in patients treated with this regimen.
- Correlate pre-treatment clinical and biological characteristics with response to therapy in these patients and the toxicity of this regimen.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and pegylated doxorubicin HCl liposome IV over 1 hour on day 4. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks for 2 years and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed symptomatic multiple myeloma meeting the following conditions:
- Monoclonal serum AND/OR urine protein
- Clonal bone marrow plasmacytosis OR histologically confirmed plasmacytoma
- Related organ tissue impairment comprising at least 1 of the following:
- Hypercalcemia
- Serum calcium more than 0.25 mmol/L above upper limit of normal (ULN) OR > 11.5 mg/dL
- Renal insufficiency
- Creatinine > 173 mmol/L
- Anemia
- Hemoglobin 2 g/dL below lower limit of normal OR hemoglobin < 10 g/dL
- One of the following bony lesions
- Lytic bony lesions
- Osteoporosis with compression fractures
- Other findings, such as symptomatic hyperviscosity, amyloidosis, or recurring bacterial infections (> 2 episodes in 12 months)
- Must be registered to companion protocol (cytogenetic studies in acute leukemia)
- Recommend registration to companion protocol CALGB-9665 (Leukemia Tissue Bank)
PATIENT CHARACTERISTICS: Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8 mg/dL (transfusion and/or growth factors allowed)
Hepatic
Renal
- See Disease Characteristics
- Creatinine < 2.5 mg/dL OR
- Creatinine clearance ≥ 30 mL/min
Cardiovascular
- Adequate cardiovascular function defined as the following:
- LVEF ≥ 45 % by echocardiography, radionuclide ventriculography, or MUGA
- No EKG evidence of acute ischemia OR evidence of medically significant conduction system abnormalities
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV congestive heart failure
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No hypersensitivity reaction to pegylated doxorubicin HCl liposome, doxorubicin, bortezomib, or other boronic acid-based compounds
PRIOR CONCURRENT THERAPY: Biologic therapy
- Prior plasmapheresis with plasma exchange (PLEX) for hyperviscosity syndrome allowed provided the patient has no concurrent evidence of hyperviscosity
- At least 1 week since prior PLEX
- Prior epoetin alfa allowed
- No concurrent pegfilgrastim
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- At least 2 weeks since prior corticosteroids for indications other than multiple myeloma
Radiotherapy
- At least 3 weeks since prior radiotherapy for the following:
- Areas of spinal cord compression by plasmacytomas
- Painful lesions due to bony involvement
- Other myeloma-related indications
- No other prior radiotherapy
Surgery
- At least 3 weeks since prior surgical intervention (e.g., for bony fractures or other myeloma-related complications) and recovered
Other
- Prior bisphosphonates allowed
- No other prior therapy for multiple myeloma
- No concurrent antiretroviral therapy for HIV-positive patients
Location and Contact Information
Alabama
Northeast Alabama Regional Medical Center, Anniston, Alabama, 36207, United States; Recruiting
Thomas W. Twele, MD 256-236-2549
California
Naval Medical Center - San Diego, San Diego, California, 92134-3202, United States; Recruiting
Preston Gable, MD 619-532-7303 pgable@nmcsd.med.navy.mil
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
Stephen L. Seagren, MD 619-543-5303
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting
Alan T. Lefor, MD 310-423-5874 Alan.Lefor@cshs.org
UCSF Comprehensive Cancer Center, San Francisco, California, 94115, United States; Recruiting
Alan Paul Venook, MD 800-888-8664 venook@cc.ucsf.edu
Veterans Affairs Medical Center - San Diego, San Diego, California, 92161, United States; Recruiting
Saeeda Kirmani, MD 619-552-8585 ext. 3356 skirmani@ucsd.edu
Veterans Affairs Medical Center - San Francisco, San Francisco, California, 94121, United States; Recruiting
Patricia A. Cornett, MD 415-221-4810 ext. 3423 patricia.cornett@med.va.gov
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting
Edward P. Gelmann, MD 202-444-7303 gelmanne@georgetown.edu
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States; Recruiting
Thomas Joseph Reid, MD, PhD, FACP 202-782-5762 thomas.reid@na.amedd.army.mil
Florida
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
Luis Ramon Barreras, MD, FACP 954-771-0692
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States; Recruiting
Rogerio C. Lilenbaum, MD 305-674-2625
Florida Hospital Cancer Institute, Orlando, Florida, 32804, United States; Recruiting
Jane Crofton, RN, BSN, OCN 407-303-2090
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, 33021, United States; Recruiting
Atif M. Hussein, MD 954-986-6363 ahussein@mhs.net
Palm Beach Cancer Institute - West Palm Beach, West Palm Beach, Florida, 33401, United States; Recruiting
Robert J. Jacobson, MB, ChB, FACP, FRCP(C) 561-366-4150
Illinois
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
Center for Cancer Care at OSF Saint Anthony Medical Center, Rockford, Illinois, 61108, United States; Recruiting
Richard E. Nora, MD 815-227-2633 richard.nora@osfhealthcare.org
Louis A. Weiss Memorial Hospital, Chicago, Illinois, 60640, United States; Recruiting
Keith L. Shulman, MD 773-564-5022 KShulman@weisshospital.org
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Karen Wendling 773-834-7424
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Thomas E. Felman, MD 773-257-6074
West Suburban Center for Cancer Care, River Forest, Illinois, 60305, United States; Recruiting
John L. Showel, MD 708-763-2700 doc.shoj@wsmc.org
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Rafat H. Ansari, MD, FACP 574-284-7977
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, 46885-5099, United States; Recruiting
Sreenivasa Rao Nattam, MD 260-484-8830 ledgar@fwmoh.com
Iowa
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
Gerald H. Clamon, MD 319-356-8110
Kentucky
Baptist Hospital East - Louisville, Louisville, Kentucky, 40207, United States; Recruiting
Daniel C. Scullin, MD 502-897-1166
Maryland
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting
Martin J. Edelman, MD 410-328-2703 medelman@umm.edu
Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
George P. Canellos, MD 617-632-3470 george_canellos@dfci.harvard.edu
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Pankaj Bhargava 508-856-6884 bhargavp@ummhc.org
Michigan
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
Kathleen Jo Yost, MD 616-391-1230
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, 49085, United States; Recruiting
Cynthia Bender, BA, CRA 269-985-4516 cbender@lakelandregional.org
Minnesota
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Bruce A. Peterson, MD 612-624-5631
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417, United States; Recruiting
Vicki A. Morrison, MD 612-467-4135 morri002@tc.umn.edu
Missouri
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
Michael C. Perry, MD 573-882-4979 perrym@health.missouri.edu
Missouri Baptist Cancer Center, Saint Louis, Missouri, 63131, United States; Recruiting
Alan Philip Lyss, MD 314-996-5514 alyss@bjc.org
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
Nancy L. Bartlett, MD 314-362-4843
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, 65201, United States; Recruiting
William P. Patterson, MD 573-882-6163
Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States; Recruiting
Margaret Anne Kessinger, MD 402-559-7511 makessin@unmc.edu
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, 89106, United States; Recruiting
Chitha R. Hulugalle, MD 702-696-3000
New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
Marc Stuart Ernstoff, MD 603-650-5534 Marc.S.Ernstoff@Hitchcock.org
New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, 08103, United States; Recruiting
Edison Catalano, MD 856-342-2506
New York
CCOP - North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Vincent P. Vinciguerra, MD 516-562-8954
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, 13057, United States; Recruiting
Jeffrey J. Kirshner, MD 315-472-7504
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Clifford A. Hudis, MD 212-639-6483
Mount Sinai Medical Center, New York, New York, 10029, United States; Recruiting
Lewis R. Silverman, MD 212-241-5520 lewis.silverman@mssm.edu
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
Scott Wadler, MD 212-746-2844 scw2004@med.cornell.edu
North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Daniel R. Budman, MD 516-562-8958
Queens Cancer Center of Queens Hospital, Jamaica, New York, 11432, United States; Recruiting
Hans W. Grunwald, MD 718-883-4118 hans.grunwald@mssm.edu
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Ellis G. Levine, MD 716-845-8547
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Stephen L. Graziano, MD 315-464-8200 grazians@upstate.edu
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, 14215, United States; Recruiting
Lynn Marie Steinbrenner, MD 716-862-3191 lynn.steinbrenner@med.va.gov
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, 13210, United States; Recruiting
Leslie Marion Howard, MD 315-476-7461 ext. 4018 leslie.howard@med.va.gov
North Carolina
Cape Fear Valley Medical Center, Fayetteville, North Carolina, 28302-2000, United States; Recruiting
Kamal M. Bakri, MD 910-609-6910
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States; Recruiting
Ellen M. Willard, MD 910-295-9205
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States; Recruiting
David Duane Hurd, MD 336-716-2088 dhurd@wfubmc.edu
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Jeffrey Crawford, MD 919-684-5621 crawf006@mc.duke.edu
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7295, United States; Recruiting
Thomas C. Shea, MD 919-966-7746 sheaT@med.unc.edu
NorthEast Oncology Associates - Concord, Concord, North Carolina, 28025, United States; Recruiting
James Grier Wall, MD 704-783-1370 jwall@northeastmedical.org
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, 28805-9913, United States; Recruiting
John C. Lucke, MD 828-299-2540
Veterans Affairs Medical Center - Durham, Durham, North Carolina, 27705, United States; Recruiting
Michael J. Kelley, MD 919-286-0411 ext. 7326
Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina, 28402-9025, United States; Recruiting
Cyrus A. Kotwall, MD 910-763-4630
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting
Clara D. Bloomfield, MD 614-293-7518 bloomfield-1@medctr.osu.edu
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Howard Ozer, MD, PhD 405-271-4022
Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, 15224, United States; Recruiting
Richard K. Shadduck, MD 412-578-4355 rshadduck@msn.com
Rhode Island
Miriam Hospital at Lifespan, Providence, Rhode Island, 02906, United States; Recruiting
William M. Sikov, MD 401-793-7151 wsikov@lifespan.org
Texas
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390-8852, United States; Recruiting
Debasish Tripathy, MD 214-648-7705
Veterans Affairs Medical Center - Dallas, Dallas, Texas, 75219, United States; Recruiting
Jonathan Dowell, MD 214-857-0737
Vermont
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting
Hyman Bernard Muss, MD 802-847-3827
Virginia
Martha Jefferson Hospital, Charlottesville, Virginia, 22902, United States; Recruiting
Stefan M. Gorsch, MD 434-982-8410
MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting
John D. Roberts, MD 804-828-0450
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke, Virginia, 24014, United States; Recruiting
Paul D. Richards, MD 540-982-0237 paul.richards@usoncology.com
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, 23502, United States; Recruiting
Paul R. Conkling, MD 757-466-8683
West Virginia
St. Mary's Medical Center, Huntington, West Virginia, 25701, United States; Recruiting
Gerrit A. Kimmey, MD 304-528-4645
Study chairs or principal investigators
Robert Z. Orlowski, MD, PhD, Study Chair, UNC Lineberger Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000377483; CALGB-10301; NCT00088855
Record last reviewed: August 2004
Last Updated: April 5, 2005
Record first received: August 4, 2004
ClinicalTrials.gov Identifier: NCT00088855
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: August 2004
Last Updated: April 5, 2005
Record first received: August 4, 2004
ClinicalTrials.gov Identifier: NCT00088855
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Adriamycin (Drug Digest)
- Doxorubicin (Drug Digest)
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