Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

September 19, 2013 updated by: Riverside Haematology Group

A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

660

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riverside Haematology Group

Investigators

  • Study Chair: Diana Samson, MD, Hammersmith Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

February 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066676
  • RHG-MM97
  • EU-98030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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