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A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients With Refractory Multiple Myeloma


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients With Refractory Multiple Myeloma


OBJECTIVES: I. Compare the overall and progression-free survival and remission rates in
patients with refractory multiple myeloma treated with dexamethasone, cyclophosphamide,
etoposide, cisplatin, and filgrastim (G-CSF) with or without thalidomide. II. Compare the
qualitative and quantitative toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
transplantation (yes vs no), prior treatment failure (resistant vs relapsing), prior
treatment regimens (1-2 vs 3-4), and prior thalidomide (no vs some). Patients are randomized
to one of two treatment arms. Arm I: Patients receive oral dexamethasone daily and
cyclophosphamide, etoposide, and cisplatin (DCEP) IV continuously on days 1-4. Patients also
receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until
blood counts recover. Treatment continues every 3-4 weeks for 3 courses. Patients achieving
stable disease or better proceed to maintenance chemotherapy with DCEP administered every 8
weeks for 3 additional courses. Arm II: Patients receive chemotherapy with DCEP as in arm I
plus oral thalidomide daily. Thalidomide continues with maintenance chemotherapy and then
continues after chemotherapy is completed until disease progression. Patients are followed
every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I, II, or III
multiple myeloma with protein criteria present Quantifiable M-components of IgG, IgA, IgD,
IgE AND/OR Urinary kappa or lambda light chain excretion No IgM peaks Quantifiable
monoclonal proteins Received at least 1, but no more than 4 prior treatment regimens,
including the following: Chemotherapy Bone marrow transplantation Biologic therapy
Radiotherapy Interferon therapy or steroid pulsing given as maintenance therapy after
transplantation or chemotherapy is not considered a separate treatment regimen Progressive
disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 (3-4 allowed if
due solely to bone pain) Life expectancy: At least 3 months Hematopoietic: Absolute
granulocyte count at least 1,000/mm3 Platelet count at least 50,000/mm3 (at least 50%
plasma cells in bone marrow) Hepatic: Bilirubin no greater than 2.5 times upper limit of
normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than
2.0 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use 2 methods of effective contraception for
4 weeks before, during, and for 4 weeks after study No other prior or concurrent
malignancies within the past 5 years except adequately treated basal cell or squamous cell
skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or
II cancer in complete remission No grade 2 or greater preexisting peripheral neuropathy

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior thalidomide
allowed if received less than 3 months of therapy Recovered from prior biologic therapy
Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and
recovered No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics
No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 3 weeks
since prior extensive or limited radiotherapy and recovered No concurrent radiotherapy
Surgery: Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS

Outcome Description:

Length of time until progression - 25% increase from the baseline in myeloma protein production of other signs of disease progression such as hypercalcemia.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Mohamad A. Hussein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000067848

NCT ID:

NCT00005834

Start Date:

April 2000

Completion Date:

November 2007

Related Keywords:

  • Multiple Myeloma
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - DuluthDuluth, Minnesota  55805
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer CenterPortland, Oregon  97201-3098
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Hematology Oncology AssociatesAtlantis, Florida  33462