Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy and Interferon alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed under 65 MRC-LEUK-MYEL-VII EU-94030, NCT00002599

Objectives

I.  Compare survival of patients under age 65 with myeloma treated with 
standard ABCM (doxorubicin, carmustine, cyclophosphamide, melphalan) vs. 
intensive C-VAMP (cyclophosphamide, vincristine, doxorubicin, 
methylprednisolone) followed by high-dose melphalan (with or without 
total-body irradiation) with bone marrow and peripheral blood stem cell 
support, both with IFN-A maintenance.

II.  Compare the toxicity profiles of the 2 treatment arms.

III.  Compare the 2 treatment arms with respect to quality of life and health 
economics issues.

IV.  Investigate cellular changes by means of linked morphology, phenotype, 
and cytogenetics studies before and after treatment and at relapse.

Entry Criteria

Disease Characteristics:

Definite myeloma requiring chemotherapy and fulfilling at least
2 of the following criteria:
  Neoplastic plasma cell infiltrate and/or microplasmacytomas
  on bone marrow aspiration and/or trephine

  Paraprotein in blood and/or urine

  Definite lytic bone lesions (not simply osteoporosis)

No equivocal myeloma (such patients should be registered with
the Clinical Trial Service Unit, Oxford)

Prior/Concurrent Therapy:

No prior therapy other than minimal local radiotherapy for
relief of bone pain

Patient Characteristics:

Age:
  Under 65

Performance status:
  Not specified

Hematopoietic:
  (following rehydration and treatment for infection, if
  necessary)
  ANC at least 1,000
  Platelets at least 50,000

Hepatic:
  Not specified

Renal:
  Renal insufficiency does not necessarily exclude (dose
  reduction may be applicable)

Cardiovascular:
  No severe cardiac disease
  Past history of ischemic heart disease may exclude at the
     discretion of the investigator

Pulmonary:
  No severe respiratory illness

Other:
  Ability to tolerate at least 3 liters/day of fluid
  No life-threatening disease unrelated to myeloma
  Prior or concurrent psychiatric disorder may exclude at the
     discretion of the investigator
  No prior malignancy except:
     Nonmelanomatous skin tumors
     In situ carcinomas

Expected Enrollment

750 patients will be accrued.

Outline

Randomized study.  The following acronyms are used:
  ABM      Autologous Bone Marrow
  BCNU     Carmustine, NSC-409962
  CTX      Cyclophosphamide, NSC-26271
  DOX      Doxorubicin, NSC-123127
  G-CSF    Granulocyte Colony Stimulating Factor (Amgen),
           NSC-614629
  GM-CSF   Granulocyte-Macrophage Colony Stimulating Factor
           (source not specified)
  IFN-A    Interferon alpha (Hoffmann-La Roche), NSC-367982
  L-PAM    Melphalan, NSC-8806
  MePRDL   Methylprednisolone, NSC-19987
  PBSC     Peripheral Blood Stem Cells
  PRED     Prednisone, NSC-10023
  TBI      Total-Body Irradiation
  VCR      Vincristine, NSC-67574

ARM I.

Induction:  4-Drug Combination Chemotherapy or, as indicated, 2-Drug 
Combination Chemotherapy.  ABCM:  DOX; BCNU; CTX; L-PAM; or, if pretreatment 
ANC and platelets are less than 1,300 and 75,000, CTX; PRED.

Maintenance:  Biological Response Modifier Therapy.  IFN-A.

ARM II.

Induction:  4-Drug Combination Chemotherapy followed by Hematopoietic 
Stimulation.  C-VAMP:  DOX; VCR; MePRDL; CTX; followed by CTX; G-CSF or GM-CSF.

Consolidation:  3-Drug Combination Chemoablation with or without Radioablation 
followed by Hematopoietic Rescue.  CTX; L-PAM; MePRDL; with or without TBI 
using megavoltage equipment (linear accelerator preferred); followed by ABM 
and/or PBSC.

Maintenance:  Biological Response Modifier Therapy.  IFN-A.

Trial Contact Information

Trial Lead Organizations

Medical Research Council's Working Party on Leukemia in Adults and Children

J. Child, MD, Protocol chair(Contact information may not be current)		Ph: 44-113-392- 5153 Email: tony.child@leedsth.nhs.uk

Registry Information
Official Title		MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS: MYELOMATOSIS THERAPY TRIAL
Trial Start Date		1994-09-01
Registered in ClinicalTrials.gov		NCT00002599
Date Submitted to PDQ		1994-09-01
Information Last Verified		2007-05-08