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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
Not Enrolling
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

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:


Study Design:

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

Outcome Measure:


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:


Principal Investigator

Mohamad A. Hussein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




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



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