Clinical Trial: Bortezomib and Liposomal Doxorubicin in Treating Patients With Multiple Myeloma

This study is currently recruiting patients.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Secondary

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

  • ALT and AST ≤ 2.5 times ULN
  • Bilirubin ≤ 1.2 times ULN
  • No hepatitis A, B, or C viral infection

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


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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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