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S9922 Combination Chemo Plus Filgrastim With or Without Thalidomide in Refractory Multiple Myeloma

This study has been terminated.
(poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00005834
First received: June 2, 2000
Last updated: June 5, 2012
Last verified: June 2012

June 2, 2000
June 5, 2012
April 2000
November 2003   (final data collection date for primary outcome measure)
PFS [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Length of time until progression - 25% increase from the baseline in myeloma protein production of other signs of disease progression such as hypercalcemia.
Not Provided
Complete list of historical versions of study NCT00005834 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
S9922 Combination Chemo Plus Filgrastim With or Without Thalidomide in Refractory Multiple Myeloma
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

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide for multiple myeloma.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without thalidomide in treating patients who have 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Biological: filgrastim
    Arms 1 and 2: 300 mcg (pts </= 60 kg) or 480 mcg (pts > 60 kg), SC beginning day 5
    Other Name: G-CSF
  • Drug: cisplatin
    Arms 1 and 2: 15 mg/m2/d continuous IV days 1-4
    Other Name: platinol
  • Drug: cyclophosphamide
    Arms 1 and 2: 400 mg/m2/d continuous IV days 1-4
    Other Name: cytoxan
  • Drug: dexamethasone
    Arms 1 and 2: 40 mg/d PO days 1-4
    Other Name: decadron
  • Drug: etoposide
    Arms 1 and 2: 40 mg/m2/d continuous IV days 1-4
    Other Name: VP-16
  • Drug: thalidomide
    Arm 2: 800 mg/d (max dose) PO daily
    Other Name: thalomid
  • Experimental: chemo with thalidomide
    chemo with thalidomide
    Interventions:
    • Biological: filgrastim
    • Drug: cisplatin
    • Drug: cyclophosphamide
    • Drug: dexamethasone
    • Drug: etoposide
    • Drug: thalidomide
  • Active Comparator: chemo without thalidomide
    chemo without thalidomide
    Interventions:
    • Biological: filgrastim
    • Drug: cisplatin
    • Drug: cyclophosphamide
    • Drug: dexamethasone
    • Drug: etoposide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
November 2007
November 2003   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005834
CDR0000067848, S9922, U10CA032102
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Mohamad A. Hussein, MD The Cleveland Clinic
Southwest Oncology Group
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP