Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006232
First received: September 11, 2000
Last updated: May 14, 2013
Last verified: March 2007
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for multiple myeloma.

PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: idarubicin
Drug: vincristine sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Comparison of response rates [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to achieve a maximal response [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 1996
Study Completion Date: August 2007
Detailed Description:

OBJECTIVES:

  • Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprising idarubicin and dexamethasone vs vincristine, doxorubicin, and dexamethasone.
  • Compare the disease progression, time to achieve maximal response, and duration of response in patients treated with these 2 regimens.
  • Compare the quality of life of patients treated with these 2 regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral idarubicin and oral dexamethasone daily on days 1-4. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone daily on days 8-11 during course 1 only.
  • Arm II: Patients receive oral dexamethasone daily, doxorubicin IV continuously, and vincristine IV continuously on days 1-4. Courses repeat as in arm I. Patients receive additional dexamethasone as in arm I.

Patients without a maximal response after completion of course 4 may receive up to 2 additional courses.

Quality of life is assessed at baseline and then prior to each study course.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of stage II or III multiple myeloma

    • No prior therapy except local radiotherapy to bone lesions
  • No indolent multiple myeloma
  • No monoclonal gammopathy of unknown significance

PATIENT CHARACTERISTICS:

Age:

  • 75 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2.34 mg/dL

Renal:

  • No end stage renal failure (creatinine greater than 5.65 mg/dL after rehydration)
  • No requirement for dialysis

Other:

  • No other medical condition that would preclude intensive treatment
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • Concurrent local radiotherapy allowed for painful lesions or lesions that appear likely to lead to an imminent fracture

Surgery

  • See Disease Characteristics
  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: NCT00006232

Locations
United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Royal Liverpool and Broadgreen Hospitals NHS Trust
Liverpool, England, United Kingdom, L7 8XP
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Centre for Cancer Research and Cell Biology at Belfast City Hospital
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Vale Of Leven D G Hospital
Alexandria, Scotland, United Kingdom, G83 0UA
Dumfries Royal Infirmary
Dumfries, Scotland, United Kingdom, DG1 4AP
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom, DD1 9SY
West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom, G4 0SF
Royal Alexandra Hospital
Paisley, Scotland, United Kingdom
Sponsors and Collaborators
West of Scotland Lymphoma Group
Investigators
Study Chair: Gordon Cook, MD, PhD Leeds Cancer Centre at St. James's University Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006232     History of Changes
Other Study ID Numbers: WSLG-H31, CDR0000068156, EU-20032, ISRCTN65684689
Study First Received: September 11, 2000
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Dexamethasone
Doxorubicin
Liposomal doxorubicin
Vincristine
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents

ClinicalTrials.gov processed this record on October 22, 2014