Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03336073
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-09-07
First Post:
2017-10-25
Brief Title:
Carfilzomib Cyclophosphamide Dexamethasone in Multiple Myeloma
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
Carfilzomib and Dexamethasone in Combination With Cyclophosphamide vs Carfilzomib and Dexamethasone in Patients With RelapsedRefractory Multiple Myeloma a Phase II Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
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:
This is a multicenter open label phase II randomized controlled study that will evaluate the efficacy of carfilzomib and dexamethasone in combination with cyclophosphamide in RR MM patients
For this purpose RR MM patients that have received 1-3 prior lines of therapy and who are not primary refractory or refractory to proteasome inhibitors will be randomized to receive
Experimental arm carfilzomib at a dose of 70 mgm2 20 mgm2 only in the first infusion intravenously iv on days 1 8 and 15 dexamethasone by mouth po at a dose of 20 mg 10 mg for patients 75 years days 1 2 8 9 15 and 16 and cyclophosphamide at a dose of 300 mgm2 iv on days 1 8 and 15 in 28 days cycles or
Control arm the same treatment but without cyclophosphamide
Once the first 12 cycles are administered treatment will be administered on days 1 and 15 of each cycle and the visit and doses on day 8 will be omitted in both study arms
Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mgm2 20 mgm2 only in the first infusion during the cycles 1 and 2 If tolerability is acceptable the dose could be increased up to 70 mgm2 since the cycle 3
Treatment will be continued until progression unacceptable toxicity or investigator or patient decision
For this purpose RR MM patients that have received 1-3 prior lines of therapy and who are not primary refractory or refractory to proteasome inhibitors will be randomized to receive
Experimental arm carfilzomib at a dose of 70 mgm2 20 mgm2 only in the first infusion intravenously iv on days 1 8 and 15 dexamethasone by mouth po at a dose of 20 mg 10 mg for patients 75 years days 1 2 8 9 15 and 16 and cyclophosphamide at a dose of 300 mgm2 iv on days 1 8 and 15 in 28 days cycles or
Control arm the same treatment but without cyclophosphamide
Once the first 12 cycles are administered treatment will be administered on days 1 and 15 of each cycle and the visit and doses on day 8 will be omitted in both study arms
Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mgm2 20 mgm2 only in the first infusion during the cycles 1 and 2 If tolerability is acceptable the dose could be increased up to 70 mgm2 since the cycle 3
Treatment will be continued until progression unacceptable toxicity or investigator or patient decision
Detailed Description:
Treatment will consist of 28-days cycles with
Arm 1 experimental arm
Carfilzomib administered iv at a dose of 70 mgm2 20 mgm2 only in the first infusion iv on days 1 8 and 15
Dexamethasone at a dose of 20 mg po 10 mg for patients 75 years days 1 2 8 9 15 and 16
Cyclophosphamide at a dose of 300 mgm2 iv on days 1 8 and 15
Arm 2 control arm
Carfilzomib administered iv at a dose of 70 mgm2 20 mgm2 only in the first infusion iv on days 1 8 and 15
Dexamethasone at a dose of 20 mg po 10 mg for patients 75 years days 1 2 8 9 15 and 16
Once the first 12 cycles are administered treatment will be administered on days 1 and 15 of each cycle and the visit and doses on day 8 will be omitted in both study arms
Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mgm2 20 mgm2 only in the first infusion during the cycles 1 and 2 If tolerability is acceptable the dose could be increased up to 70 mgm2 since the cycle 3
Treatments will be administered until progressive disease PD or unacceptable toxicity Carfilzomib and cyclophosphamide will be provided by the sponsor Dexamethasone may be utilized per a sites standard practice and will not be provided by the sponsor
Arm 1 experimental arm
Carfilzomib administered iv at a dose of 70 mgm2 20 mgm2 only in the first infusion iv on days 1 8 and 15
Dexamethasone at a dose of 20 mg po 10 mg for patients 75 years days 1 2 8 9 15 and 16
Cyclophosphamide at a dose of 300 mgm2 iv on days 1 8 and 15
Arm 2 control arm
Carfilzomib administered iv at a dose of 70 mgm2 20 mgm2 only in the first infusion iv on days 1 8 and 15
Dexamethasone at a dose of 20 mg po 10 mg for patients 75 years days 1 2 8 9 15 and 16
Once the first 12 cycles are administered treatment will be administered on days 1 and 15 of each cycle and the visit and doses on day 8 will be omitted in both study arms
Patients older than 75 years will receive in both arms carfilzomib at a dose of 56 mgm2 20 mgm2 only in the first infusion during the cycles 1 and 2 If tolerability is acceptable the dose could be increased up to 70 mgm2 since the cycle 3
Treatments will be administered until progressive disease PD or unacceptable toxicity Carfilzomib and cyclophosphamide will be provided by the sponsor Dexamethasone may be utilized per a sites standard practice and will not be provided by the sponsor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None