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Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003603
First Posted: January 27, 2003
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: cyclophosphamide Drug: dexamethasone Drug: idarubicin Drug: lomustine Drug: melphalan Drug: prednisolone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomised Study Comparing CIDEX (CCNU, Oral Idarubicin and Dexamethasone) With Melphalan and Prednisolone in Relapsed Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 660
Study Start Date: March 1998
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003603


Locations
United Kingdom
Hammersmith Hospital
London, England, United Kingdom, W12 ONN
Sponsors and Collaborators
Riverside Haematology Group
Investigators
Study Chair: Diana Samson, MD Hammersmith Hospitals NHS Trust
  More Information

ClinicalTrials.gov Identifier: NCT00003603     History of Changes
Other Study ID Numbers: CDR0000066676
RHG-MM97
EU-98030
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: September 20, 2013
Last Verified: February 2001

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Dexamethasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Cyclophosphamide
Melphalan
Idarubicin
Lomustine
BB 1101
Anti-Inflammatory Agents