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Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
cyclophosphamide
dexamethasone
idarubicin
lomustine
melphalan
prednisolone
Sponsored by
Riverside Haematology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma based on at least two of the following: Paraprotein in serum and/or urine Greater than 10% plasma cells in bone marrow Lytic bone lesions Measurable serum and/or urine paraprotein Progression from first or second stable plateau phase No non-secretory myeloma or plasma cell leukemia (greater than 2,000/mm^3 circulating plasma cells) No primary refractory disease or second or later relapse PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-3 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,000/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN Renal: Creatinine less than 3.4 mg/dL Cardiovascular: No clinically significant cardiac insufficiency No uncontrolled hypertension Other: No uncontrolled diabetes mellitus No recent history of peptic ulceration HIV-1 and HIV-2 negative Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic peripheral blood stem cell or bone marrow transplantation No planned future autologous transplantation unless sufficient stored stem cells available Prior interferon allowed if administered as maintenance of stable plateau phase No concurrent epoetin alfa Chemotherapy: At least 3 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy for pain or to treat localized tumors allowed Surgery: Not specified Other: No prior participation in any clinical trial with an unlicensed product

Sites / Locations

  • Hammersmith Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 19, 2013
Sponsor
Riverside Haematology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00003603
Brief Title
Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma
Official Title
A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2001
Overall Recruitment Status
Unknown status
Study Start Date
March 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Riverside Haematology Group

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Steroids, such as dexamethasone or prednisolone, may help relieve some of the side effects of chemotherapy. It is not yet known which regimen of chemotherapy plus steroid therapy is more effective in treating patients with multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy plus steroid therapy in treating patients with multiple myeloma that has recurred for the first time.
Detailed Description
OBJECTIVES: Compare the response rate, response duration, and survival of patients with relapsed multiple myeloma after treatment with lomustine, idarubicin, and dexamethasone vs melphalan and prednisolone. OUTLINE: This is a randomized study. Patients are stratified according to prior autologous transplant (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral lomustine on day 1, oral idarubicin once daily on days 1-3, and oral dexamethasone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression. Arm II: Patients receive oral melphalan once daily on days 1-4 and oral prednisolone twice a day on days 1-4. Treatment is repeated every 28 days for 6-9 courses in the absence of unacceptable toxicity or disease progression. Some patients may receive oral cyclophosphamide every 7 days and oral prednisolone on alternate days for 6 weeks concurrently with chemotherapy in either treatment arm. Quality of life is assessed at baseline, at 3, 6, 9, and 12 months, and then every 6 months thereafter. Patients are followed until death. PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
idarubicin
Intervention Type
Drug
Intervention Name(s)
lomustine
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
prednisolone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma based on at least two of the following: Paraprotein in serum and/or urine Greater than 10% plasma cells in bone marrow Lytic bone lesions Measurable serum and/or urine paraprotein Progression from first or second stable plateau phase No non-secretory myeloma or plasma cell leukemia (greater than 2,000/mm^3 circulating plasma cells) No primary refractory disease or second or later relapse PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-3 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,000/mm^3 Platelet count at least 75,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN Renal: Creatinine less than 3.4 mg/dL Cardiovascular: No clinically significant cardiac insufficiency No uncontrolled hypertension Other: No uncontrolled diabetes mellitus No recent history of peptic ulceration HIV-1 and HIV-2 negative Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic peripheral blood stem cell or bone marrow transplantation No planned future autologous transplantation unless sufficient stored stem cells available Prior interferon allowed if administered as maintenance of stable plateau phase No concurrent epoetin alfa Chemotherapy: At least 3 months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy for pain or to treat localized tumors allowed Surgery: Not specified Other: No prior participation in any clinical trial with an unlicensed product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Samson, MD
Organizational Affiliation
Hammersmith Hospitals NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Hammersmith Hospital
City
London
State/Province
England
ZIP/Postal Code
W12 ONN
Country
United Kingdom

12. IPD Sharing Statement

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Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

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