Clinical Trial: High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis

This study is currently recruiting patients.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)


RATIONALE: Drugs used in chemotherapy such as melphalan work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining high-dose melphalan with autologous stem cell transplantation in treating patients who have multiple myeloma or primary systemic amyloidosis.

Condition Treatment or Intervention Phase
primary systemic amyloidosis
stage II multiple myeloma
stage III multiple myeloma
 Drug: cyclophosphamide
 Drug: dexamethasone
 Drug: filgrastim
 Drug: melphalan
 Drug: thalidomide
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: growth factor antagonist therapy
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:  Metabolic Disorders;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of High-Dose Melphalan and Autologous Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Multiple Myeloma or Primary Systemic Amyloidosis

Further Study Details: 


OUTLINE: This is a multicenter study. Patients are stratified according to disease (high-risk multiple myeloma vs primary systemic amyloidosis vs both).

  • Induction therapy (multiple myeloma patients only): Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral thalidomide daily on days 1-35. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity.
  • Multiple myeloma patients: Within 28-35 days after completion of induction therapy, patients receive cyclophosphamide IV over 2-3 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 2 and continuing through the day before the last leukapheresis.
  • Primary systemic amyloidosis patients: Patients receive G-CSF SC daily beginning on day 1 and continuing through the day before the last leukapheresis. All patients undergo leukapheresis for the collection of stem cells until the target number of CD34+ cells is reached.
  • Conditioning regimen: Within 1-4 weeks after mobilization, patients receive modified high-dose melphalan IV over 20 minutes on day -2.
  • Peripheral blood stem cell (PBSC) reinfusion: PBSCs are reinfused on day 0. Patients receive G-CSF SC daily beginning on day 1 and continuing until blood counts recover. Patients undergo a second autologous PBSC transplantation within 3-6 months, but no later than 12 months, after the first transplantation.
  • Second conditioning regimen: Patients receive modified high-dose melphalan IV over 20 minutes on day -2.
  • Second PBSC infusion: PBSCs are infused on day 0.
  • Maintenance regimen (multiple myeloma patients only): Between 4-8 weeks after the second transplantation, patients with no progressive disease receive oral dexamethasone once daily on days 1-4 and oral thalidomide once daily on days 1-28. Courses repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 and 6 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 20-25 months.


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • At least 1 of the following diagnoses:
  • Multiple myeloma
  • Stage II or III disease
  • At least 1 of the following must be present:
  • Serum M-protein of IgG, IgA, IgD, IgE greater than 1.0 g/dL
  • Urinary M-protein (Bence-Jones) at least 200 mg/24 hours
  • No IgM peaks
  • No monoclonal gammopathy of undetermined significance
  • No indolent or smoldering myeloma
  • No more than 1 prior treatment for multiple myeloma, including any of the following:
  • Vincristine, doxorubicin, and dexamethasone
  • Dexamethasone alone
  • Cyclophosphamide
  • Thalidomide
  • No more than 3 months of prior thalidomide therapy
  • Melphalan
  • No more than 200 mg of prior melphalan therapy
  • No disease progression on prior thalidomide or dexamethasone
  • Histologically confirmed primary systemic amyloidosis
  • No senile, secondary, localized, dialysis-related, or familial amyloidosis
  • No severe cardiac involvement
  • No pre-exertional syncope, ventricular arrhythmia, or symptomatic pleural effusions associated with cardiac involvement
  • No more than 200 mg of prior melphalan therapy
  • Must have been diagnosed within the past year
  • Concurrent enrollment in the myeloma repository protocol SWOG-S0309 must be offered


Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN



  • See Disease Characteristics
  • Hemodynamically stable (i.e., systolic blood pressure > 90 mm Hg in a lying position within the past 42 days)
  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No arrhythmia refractory to medical therapy
  • LVEF greater than 45% by echocardiogram or MUGA


  • See Disease Characteristics
  • No history of chronic obstructive or chronic restrictive pulmonary disease
  • Pulmonary function studies (e.g., FEV_1 and FVC) at least 50% of predicted
  • DLCO at least 50% of predicted
  • Normal high resolution CT scan of the chest and acceptable arterial blood gases (i.e., PO_2 greater than 70) required for patients unable to complete pulmonary function tests due to bone pain or fracture


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Multiple myeloma patients receiving thalidomide must use 2 methods of effective contraception for at least 4 weeks before, during, and for at least 4 weeks after discontinuation of thalidomide
  • HIV negative
  • No other concurrent significant medical condition
  • No concurrent uncontrolled life-threatening infection
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission


  • See Disease Characteristics


  • See Disease Characteristics
  • Prior cumulative melphalan dose no more than 200 mg
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent hormonal therapy


  • No concurrent radiotherapy


  • Not specified


  • Recovered from prior therapy
  • Prior or concurrent bisphosphonates allowed

Location and Contact Information

      MBCCOP - Gulf Coast, Mobile,  Alabama,  36607,  United States; Recruiting
Paul O. Schwarzenberger, MD  251-544-1013 

      Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson,  Arizona,  85724,  United States; Recruiting
Thomas P. Miller, MD  520-626-2667 

      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
David Kyle King, MD, FACP  602-239-2413 

      Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix,  Arizona,  85012,  United States; Recruiting
Thomas Dale Kummet, MD  602-277-5551 

      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States; Recruiting
Harinder S. Garewal, MD  520-629-4686 

      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
Laura Fulper Hutchins, MD  501-686-8511 

      Veterans Affairs Medical Center - Little Rock, Little Rock,  Arkansas,  72205,  United States; Recruiting
Bart Barlogie, MD  501-526-2873 

      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States; Recruiting
Joseph Szumowski, MD  510-465-8570 

      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States; Recruiting
Ian C. Anderson, MD  707-521-3830 

      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
Randall F. Holcombe, MD  714-456-5153 

      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
Clinical Trials Office - New Patient Services  800-826-4673 

      General Robert Huyser Cancer Center at David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States; Recruiting
Kevin P. Ryan, MD  707-423-5129 

      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033,  United States; Recruiting
Heinz-Josef Lenz, MD  323-865-3955 

      Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda,  California,  92357,  United States; Recruiting
Mark E. Reeves, MD, PhD  909-583-6064 

      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States; Recruiting
David R. Gandara, MD  925-372-2064 

      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora,  Colorado,  80010,  United States; Recruiting
Anthony D. Elias, MD  720-848-1622 

      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States; Recruiting
Madeleine A. Kane, MD, PhD  303-399-8020 ext. 3129 

District of Columbia
      MBCCOP - Howard University Cancer Center, Washington,  District of Columbia,  20060,  United States; Recruiting
Lucile L. Adams-Campbell, PhD  202-806-7697 

      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Edith A. Perez, MD  904-953-7283 

      Veterans Affairs Medical Center - Tampa (Haley), Tampa,  Florida,  33612,  United States; Recruiting
Raoul R. Salup, MD  813-972-7579 

      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States; Recruiting
Thomas E. Seay, MD, PhD  404-851-2340 

      Dwight David Eisenhower Army Medical Center, Fort Gordon,  Georgia,  30905-5650,  United States; Recruiting
Phyllis Ferguson, CRA  706-787-4273 

      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Brian F. Issell, MD  808-586-3015 

      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153-5500,  United States; Recruiting
Patrick J. Stiff, MD  708-327-3148 

      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
James L. Wade, MD  217-876-6617 

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-335-3614 

      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-569-6129 

      Veterans Affairs Medical Center - Hines, Hines,  Illinois,  60141,  United States; Recruiting
Nirmala Bhoopalam, MD  708-202-2782 

      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-268-5784 

      Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City,  Kansas,  66160-7353,  United States; Recruiting
Sarah A. Taylor, MD  913-588-6029 

      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States; Recruiting
Shaker R. Dakhil, MD, FACP  316-685-2221 

      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0084,  United States; Recruiting
Michael A. Doukas, MD  859-257-3379 

      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40502-2236,  United States; Recruiting
Michael A. Doukas, MD  859-281-4956 

      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States; Recruiting
Glenn M. Mills, MD  318-675-5970 

      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Jill Gilbert, MD  504-568-5613 

      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States; Recruiting
Alan M. Miller, MD, PhD  504-587-7566 

      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States; Recruiting
German S. Beltran, MD  504-588-5482 

      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71101-4295,  United States; Recruiting
Glenn M. Mills, MD  318-221-8411 

      Cancer Research Center at Boston Medical Center, Boston,  Massachusetts,  02118,  United States; Recruiting
Douglas V. Faller, MD, PhD  617-638-4173 

      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States; Recruiting
Lawrence E. Flaherty, MD  313-745-9155 

      CCOP - Beaumont, Royal Oak,  Michigan,  48073-6769,  United States; Recruiting
Jeanne Archer, PhD, APN  248-551-8299 

      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Kathleen Jo Yost, MD  616-391-1230 

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Philip J. Stella, MD  734-712-5237 

      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
Robert Anthony Chapman, MD  313-916-1332 

      Providence Cancer Institute at Providence Hospital - Southfield, Southfield,  Michigan,  48075,  United States; Recruiting
Anibal Drelichman, MD, MPH, FACP  313-552-0620 

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0948,  United States; Recruiting
Laurence H. Baker, DO, FACOI  734-936-3983 

      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States; Recruiting
Lawrence E. Flaherty, MD  313-576-1000 

      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
James Tate Thigpen, MD  601-984-5590 

      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States; Recruiting
James Tate Thigpen, MD  601-362-4471 

      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4520 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States; Recruiting
Bethany G. Sleckman, MD  314-569-6573 

      Saint Louis University Cancer Center, Saint Louis,  Missouri,  63110,  United States; Recruiting
Paul J. Petruska, MD  314-268-5451 

      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States; Recruiting
Patrick W. Cobb, MD  406-259-2245 

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States; Recruiting
Cheryl L. Willman, MD  505-272-5837 

      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States; Recruiting
Cheryl L. Willman, MD  505-265-1711 

New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
Daniel P. Petrylak, MD  212-305-1731 

      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Richard I. Fisher, MD  585-275-0842 

      NYU Cancer Institute at New York University Medical Center, New York,  New York,  10016,  United States; Recruiting
Amy D. Tiersten, MD  212-652-1916 

North Carolina
      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
James N. Atkins, MD  336-777-3088 

      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
J. Philip Kuebler, MD, PhD  614-488-2118 

      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
Howard M. Gross, MD  937-832-1093 

      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0501,  United States; Recruiting
Abdul-Rahman Jazieh, MD, MPH  513-584-3830 

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195-9001,  United States; Recruiting
George Thomas Budd, MD  216-444-6480 

      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States; Recruiting
Albert F. Muhleman, MD  513-475-6537 

      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428-1002,  United States; Recruiting
Howard M. Gross, MD  937-268-6511 

      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97201-3098,  United States; Recruiting
Craig R. Nichols, MD  503-494-6346 

      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Keith S. Lanier, MD  503-216-6260 

      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States; Recruiting
Christopher W. Ryan, MD  503-220-8262 

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
Jeffrey Kent Giguere, MD  864-241-6251 

      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
James Dewitt Bearden, MD  864-560-7050 

      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Carolyn E. Reed, MD  843-792-9321 

      Veterans Affairs Medical Center - Charleston, Charleston,  South Carolina,  29401-5799,  United States; Recruiting
Carolyn E. Reed, MD  843-789-7804 

      University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis,  Tennessee,  38104,  United States; Recruiting
Mohammad Jahanzeb, MD  901-722-0532 

      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States; Recruiting
Harvey B. Niell, MD  901-523-8990 ext. 5533 

      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
Seth P. Lerner, MD  713-798-6841 

      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234-6200,  United States; Recruiting
Mitchell A. Garrison, MD  210-916-3281 

      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-1053 

      Harrington Cancer Center, Amarillo,  Texas,  79106,  United States; Recruiting
James E. Clarkson, MD  806-359-4673 ext. 228 

      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4095,  United States; Recruiting
Scott Michael Lippman, MD, FACP  713-745-3672 

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229-3900,  United States; Recruiting
Geoffrey R. Weiss, MD  210-567-4777 

      University of Texas Medical Branch, Galveston,  Texas,  77555-0565,  United States; Recruiting
Robert P. Whitehead, MD  409-772-1164 

      Veterans Affairs Medical Center - Amarillo, Amarillo,  Texas,  79106,  United States; Recruiting
Stephen E. Wright, MD  806-359-4673 ext. 230 

      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78229,  United States; Recruiting
Geoffrey R. Weiss, MD  210-617-5186 

      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States; Recruiting
Phalguni Mukhopadhyay, MD  254-778-4811 ext. 4809 

      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112-5550,  United States; Recruiting
Wolfram Samlowski, MD  801-585-0255 

      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States; Recruiting
Wolfram Samlowski, MD  801-582-1565 ext. 1272 

      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States; Recruiting
Lauren Kenneth Colman, MD  253-403-5259 

      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States; Recruiting
Andrew David Jacobs, MD  206-341-0446 

      Madigan Army Medical Center, Tacoma,  Washington,  98431-5000,  United States; Recruiting
Rajat Bannerji, MD, PhD  253-968-2504 

      Puget Sound Oncology Consortium, Seattle,  Washington,  98109,  United States; Recruiting
Saul E. Rivkin, MD  206-386-2441 

      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States; Recruiting
William H. Schubach, MD  206-764-2265 

Canada, British Columbia
      British Columbia Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada; Recruiting
John H. Hay, MD  604-877-6000 ext. 2660 

Study chairs or principal investigators

Vaishali Sanchorawala, MD,  Boston Medical Center   
David Cary Seldin, MD, PhD,  Boston Medical Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000315382; SWOG-S0115; NCT00064337
Record last reviewed:  September 2004
Last Updated:  April 4, 2005
Record first received:  July 8, 2003 Identifier:  NCT00064337
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005