Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

NCT ID: NCT00003603

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-03-31

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cyclophosphamide

Intervention Type: DRUG

dexamethasone

Intervention Type: DRUG

idarubicin

Intervention Type: DRUG

lomustine

Intervention Type: DRUG

melphalan

Intervention Type: DRUG

prednisolone

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riverside Haematology Group

OTHER

Sponsor Role: lead

Principal Investigators

Diana Samson, MD

Role: STUDY_CHAIR

Hammersmith Hospitals NHS Trust

Locations

Hammersmith Hospital

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

RHG-MM97

Identifier Type: -

Identifier Source: secondary_id

EU-98030

Identifier Type: -

Identifier Source: secondary_id

CDR0000066676

Identifier Type: -

Identifier Source: org_study_id