Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028886
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2002-01-04
Brief Title:
Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma
Sponsor:
Commissie Voor Klinisch Toegepast Onderzoek
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Study On The Effect Of Thalidomide Combined With Adriamycin Dexamethasone AD And High Dose Melphalan In Patients With Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2012-10
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 cancer cells from dividing so they stop growing or die Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells The donated stem cells may also help destroy any remaining cancer cells graft-versus-tumor effect It is not yet known whether chemotherapy followed by peripheral blood stem cell transplant is more effective with or without thalidomide in treating multiple myeloma
PURPOSE This randomized phase III trial is studying giving combination chemotherapy with thalidomide to see how well it works compared with giving combination chemotherapy without thalidomide in treating patients with multiple myeloma
PURPOSE This randomized phase III trial is studying giving combination chemotherapy with thalidomide to see how well it works compared with giving combination chemotherapy without thalidomide in treating patients with multiple myeloma
Detailed Description:
OBJECTIVES
Compare the efficacy of doxorubicin dexamethasone and high-dose melphalan with versus without thalidomide in terms of event-free survival of patients with multiple myeloma
Determine the response rate complete response rate overall survival and progression-free survival of patients treated with these regimens
Determine the safety and toxicity of thalidomide in combination with intensive chemotherapy in these patients
Assess the value of prognostic factors at diagnosis in individual patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and treatment policy 1 course vs 2 courses of high-dose melphalan Patients are randomized to 1 of 2 treatment arms
Arm I
Patients receive induction chemotherapy AD comprising doxorubicin IV on days 1-4 and oral dexamethasone on days 1-4 9-12 and 17-20 Patients receive oral thalidomide daily beginning on day 1 and continuing until 2 weeks before start of stem cell mobilization Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Patients receive stem cell mobilization with chemotherapy comprising cyclophosphamide IV on day 1 and doxorubicin IV and oral dexamethasone on days 1-4 CAD Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 5 and continuing until last apheresis
Beginning 8-10 weeks after stem cell collection patients receive low-dose oral thalidomide daily and high-dose melphalan IV on days -3 and -2 as intensification Patients undergo stem cell infusion on day 0 Patients may receive a second course of high-dose melphalan 2-3 months after the first course in which case stem cell infusion follows the second course of melphalan
Patients receive maintenance therapy with oral thalidomide daily until disease progression or after 3 months if no response
Beginning 2 months after the last course patients with an HLA-identical sibling donor undergo nonmyeloablative stem cell transplantation after radiotherapy
Arm II
Patients receive induction chemotherapy VAD comprising vincristine IV and doxorubicin IV on days 1-4 and dexamethasone on days 1-4 9-12 and 17-20 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Patients receive stem cell mobilization with CAD chemotherapy as in arm I G-CSF is given as in arm I
Patients receive high-dose melphalan and undergo stem cell infusion as in arm I
Patients receive maintenance therapy with interferon alfa SC 3 times weekly until progression or after 3 months if no partial response
Beginning 2 months after the last course patients with an HLA-identical sibling donor undergo nonmyeloablative stem cell transplantation after radiotherapy
All patients are followed every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 450 patients 225 per treatment arm will be accrued for this study within 4 years
Compare the efficacy of doxorubicin dexamethasone and high-dose melphalan with versus without thalidomide in terms of event-free survival of patients with multiple myeloma
Determine the response rate complete response rate overall survival and progression-free survival of patients treated with these regimens
Determine the safety and toxicity of thalidomide in combination with intensive chemotherapy in these patients
Assess the value of prognostic factors at diagnosis in individual patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and treatment policy 1 course vs 2 courses of high-dose melphalan Patients are randomized to 1 of 2 treatment arms
Arm I
Patients receive induction chemotherapy AD comprising doxorubicin IV on days 1-4 and oral dexamethasone on days 1-4 9-12 and 17-20 Patients receive oral thalidomide daily beginning on day 1 and continuing until 2 weeks before start of stem cell mobilization Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Patients receive stem cell mobilization with chemotherapy comprising cyclophosphamide IV on day 1 and doxorubicin IV and oral dexamethasone on days 1-4 CAD Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 5 and continuing until last apheresis
Beginning 8-10 weeks after stem cell collection patients receive low-dose oral thalidomide daily and high-dose melphalan IV on days -3 and -2 as intensification Patients undergo stem cell infusion on day 0 Patients may receive a second course of high-dose melphalan 2-3 months after the first course in which case stem cell infusion follows the second course of melphalan
Patients receive maintenance therapy with oral thalidomide daily until disease progression or after 3 months if no response
Beginning 2 months after the last course patients with an HLA-identical sibling donor undergo nonmyeloablative stem cell transplantation after radiotherapy
Arm II
Patients receive induction chemotherapy VAD comprising vincristine IV and doxorubicin IV on days 1-4 and dexamethasone on days 1-4 9-12 and 17-20 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Patients receive stem cell mobilization with CAD chemotherapy as in arm I G-CSF is given as in arm I
Patients receive high-dose melphalan and undergo stem cell infusion as in arm I
Patients receive maintenance therapy with interferon alfa SC 3 times weekly until progression or after 3 months if no partial response
Beginning 2 months after the last course patients with an HLA-identical sibling donor undergo nonmyeloablative stem cell transplantation after radiotherapy
All patients are followed every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 450 patients 225 per treatment arm will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HOVON-CKVO-2001-02 | None | None | None |
| CKTO-2001-02 | None | None | None |
| HOVON-50MM | None | None | None |
| EU-20133 | None | None | None |