Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

Riverside Haematology Group

Status and phase

Unknown

Phase 3

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Treatments

Drug: melphalan

Drug: cyclophosphamide

Drug: idarubicin

Drug: lomustine

Drug: dexamethasone

Drug: prednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT00003603

CDR0000066676

RHG-MM97

EU-98030

Details and patient eligibility

About

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.

Full 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.

Enrollment

660 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

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: