Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	RHG-MM97 EU-98030, NCT00003603

Objectives

1. 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.

Entry 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/mm³ circulating plasma cells)



• No primary refractory disease or second or later relapse

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• 0-3

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count at least 1,000/mm³
• Platelet count at least 75,000/mm³

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

Expected Enrollment

A total of 660 patients will be accrued for this study within 5 years.

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.

Trial Contact Information

Trial Lead Organizations

Riverside Haematology Group

Diana Samson, MD, Protocol chair		Ph: 44-181-383-4017

Registry Information
Official Title		A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) with Melphalan and Prednisolone in Relapsed Multiple Myeloma
Trial Start Date		1998-03-01
Registered in ClinicalTrials.gov		NCT00003603
Date Submitted to PDQ		1998-09-29
Information Last Verified		2001-02-16

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