Chemotherapy Plus Steroid Therapy in Treating Patients With Multiple Myeloma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003603
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: February 2001
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003603     History of Changes
Other Study ID Numbers: CDR0000066676, RHG-MM97, EU-98030
Study First Received: November 1, 1999
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Idarubicin
Melphalan
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Alkylating Agents

ClinicalTrials.gov processed this record on October 22, 2014