Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002599
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Interferon Alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MYELOMA VII MEDICAL RESEARCH COUNCIL WORKING PARTY ON LEUKEMIA IN ADULTS MYELOMATOSIS THERAPY TRIAL
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Interferon alfa may interfere with the growth of cancer cells It is not yet known whether a more intensive chemotherapy regimen plus stem cell or bone marrow transplant is more effective than standard chemotherapy in treating patients with myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy plus interferon alfa with or without high dose melphalan or bone marrow or peripheral stem cell transplantation in treating patients with previously untreated myeloma
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy plus interferon alfa with or without high dose melphalan or bone marrow or peripheral stem cell transplantation in treating patients with previously untreated myeloma
Detailed Description:
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
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 1300 and 75000 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 andor PBSC Maintenance Biological Response Modifier Therapy IFN-A
PROJECTED ACCRUAL 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 1300 and 75000 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 andor PBSC Maintenance Biological Response Modifier Therapy IFN-A
PROJECTED ACCRUAL 750 patients will be accrued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-94030 | None | None | None |
| MRC-LEUK-MYEL-VII | None | None | None |