Clinical Trial: Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

This study is no longer recruiting patients.

Sponsored by: Riverside Haematology Group
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
refractory plasma cell neoplasm
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: cyclophosphamide
 Drug: dexamethasone
 Drug: idarubicin
 Drug: lomustine
 Drug: melphalan
 Drug: prednisolone
 Procedure: chemotherapy
 Procedure: endocrine therapy
 Procedure: hormone therapy
 Procedure: steroid therapy
Phase III

MedlinePlus related topics:  Immune System and Disorders;   Lymphatic Diseases;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Lomustine, Idarubicin, and Dexamethasone Versus Melphalan and Prednisolone in Patients With Multiple Myeloma in First Relapse

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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:

Chemotherapy:

  • At least 3 months since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

Surgery:

  • Not specified

Other:

  • No prior participation in any clinical trial with an unlicensed product

Location Information


United Kingdom, England
      Hammersmith Hospital, London,  England,  W12 ONN,  United Kingdom

Study chairs or principal investigators

Diana Samson, MD,  Study Chair,  Hammersmith Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066676; RHG-MM97; EU-98030
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003603
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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