Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802356
Status:
RECRUITING
Last Update Posted:
2021-12-06
First Post:
2021-03-12
Brief Title:
Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
An Open Label Multicenter Phase II Study of Belantamab Mafodotin in Combination With VRd for the Treatment of Newly Diagnosed Transplant Eligible Multiple Myeloma Patients
Status:
RECRUITING
Status Verified Date:
2021-12
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 clinical trial evaluating the safety of the combination of belantamab mafodotin the combination treatment VRd bortezomib lenalidomide dexamethasone in newly diagnosed ND transplant eligible multiple myeloma MM patients
Eligible patients will be included in the study and they will receive three induction cycles with belantamab mafodotin 8-week cycles and six induction cycles with VRd 4-week cycles Immediately after the fourth VRd cycle and in the absence of progression or unacceptable toxicity mobilization of hematopoietic stem cells with G-CSF and subsequent apheresis will take place Then patients will receive one additional induction cycle with belantamab mafodotin 8-week cycle and two additional induction cycles with VRd 4-week cycles followed by intensification with high-dose melphalan 200mgm2 and the autologous stem cell transplant Three months after transplantation and as long as clinical and hematological conditions allow patients will receive one cycle of consolidation with belantamab mafodotin 8-week cycle and two additional cycles of consolidation with VRd 4-week cycles at the same doses as during induction and subsequently patients will receive maintenance treatment with lenalidomide continuously until disease progression patient withdrawal unacceptable toxicity loss to follow up end of study or death and belantamab mafodotin for 2 years
Eligible patients will be included in the study and they will receive three induction cycles with belantamab mafodotin 8-week cycles and six induction cycles with VRd 4-week cycles Immediately after the fourth VRd cycle and in the absence of progression or unacceptable toxicity mobilization of hematopoietic stem cells with G-CSF and subsequent apheresis will take place Then patients will receive one additional induction cycle with belantamab mafodotin 8-week cycle and two additional induction cycles with VRd 4-week cycles followed by intensification with high-dose melphalan 200mgm2 and the autologous stem cell transplant Three months after transplantation and as long as clinical and hematological conditions allow patients will receive one cycle of consolidation with belantamab mafodotin 8-week cycle and two additional cycles of consolidation with VRd 4-week cycles at the same doses as during induction and subsequently patients will receive maintenance treatment with lenalidomide continuously until disease progression patient withdrawal unacceptable toxicity loss to follow up end of study or death and belantamab mafodotin for 2 years
Detailed Description:
This is a multicenter open label clinical trial evaluating the safety of the combination of belantamab mafodotin the combination treatment VRd bortezomib lenalidomide dexamethasone in newly diagnosed ND transplant eligible multiple myeloma MM patients
The study comprise the following phases
Induction Cycles 1-6
Cycles will be of 8 weeks of duration for belantamab mafodotin and 28 days of duration for VRd
Belantamab mafodotin will be administered at the dose of 25 mgkgevery 8 weeks on day 1 intravenously
Bortezomib will be given subcutaneously at 13 mgm2 on days 1 4 8 and 11 of every 28-day cycle
Lenalidomide will be given as an oral drug in the dose of 25 mgday on days 1-21
Dexamethasone will be given as an oral drug in the dose of 20 mg on days 1 2 4 5 8 9 11 and 12
Peripheral stem cell harvest will be performed after the fourth cycle of treatment to prevent mobilization failure
Intensification with high-dose melphalan 200 mgm2 and autologous stem cell transplant ASCT will be performed as per routine practice Mobilization of hematopoietic stem cells HSCs will be carried out using high-dose G-CSF after the fourth induction cycle with VRd The dose of G-CSF used will be at the discretion of each site according to the local rules Apheresis will be initiated on day 4-5 of stimulation once the number of CD34 cells in peripheral blood have reached the minimum to proceed with the collection The minimum number of CD34 cells needed to carry out the transplant will be determined at the discretion of each site although a minimum of 2 x106 CD34Kg is recommended as well as cryopreservation storage defrosting and infusion of HSCs If mobilization fails using G-CSF alone the recommended action is to utilize plerixafor during the same procedure in order to save this time Sites should administer plerixafor in accordance with their own established procedures If this second attempt fails the site can proceed to a third mobilization attempt using cyclophosphamide plus G-CSF
Consolidation Cycles 6-8
At day 90 after autologous stem cell transplant patients will receive consolidation treatment with 1 additional cycle of belantamab mafodotin 2 additional cycles of VRd following the same scheme as in the induction
Belantamab mafodotin will be administered at the dose of 25 mgkgevery 8 weeks on day 1 intravenously
Bortezomib will be given subcutaneously at 13 mgm2 on days 1 4 8 and 11 of every 28-day cycle
Lenalidomide will be given as an oral drug in the dose of 25 mgday on days 1-21
Dexamethasone will be given as an oral drug at the dose of 20 mg on days 1 2 4 5 8 9 11 and 12 of every 28-day cycle
Maintenance
After completion of the consolidation treatment all the responding patients will receive maintenance treatment with Lenalidomide 10 mgday belantamab mafodotin 25 mgkgevery 8 weeks intravenously Lenalidomide will be administered continuously until disease progression patient withdrawal unacceptable toxicity loss to follow up end of study or death Belantamab mafodotin will be administered for 2 years until disease progression patient withdrawal loss to follow up unacceptable toxicity end of study or death
The trial has the following objectives
Objectives
Primary objective
To evaluate the safety and tolerability of the combination of belantamab mafodotin VRd in newly diagnosed transplant eligible multiple myeloma patients
Secondary objectives To assess the efficacy of belantamab mafodotin in combination with VRd in terms of response rate focusing on complete response and MRD
Efficiency of hematopoietic stem cell collection after 2 induction cycles of treatment of belantamab mafodotin 4 induction cycles of treatment of VRd
The study comprise the following phases
Induction Cycles 1-6
Cycles will be of 8 weeks of duration for belantamab mafodotin and 28 days of duration for VRd
Belantamab mafodotin will be administered at the dose of 25 mgkgevery 8 weeks on day 1 intravenously
Bortezomib will be given subcutaneously at 13 mgm2 on days 1 4 8 and 11 of every 28-day cycle
Lenalidomide will be given as an oral drug in the dose of 25 mgday on days 1-21
Dexamethasone will be given as an oral drug in the dose of 20 mg on days 1 2 4 5 8 9 11 and 12
Peripheral stem cell harvest will be performed after the fourth cycle of treatment to prevent mobilization failure
Intensification with high-dose melphalan 200 mgm2 and autologous stem cell transplant ASCT will be performed as per routine practice Mobilization of hematopoietic stem cells HSCs will be carried out using high-dose G-CSF after the fourth induction cycle with VRd The dose of G-CSF used will be at the discretion of each site according to the local rules Apheresis will be initiated on day 4-5 of stimulation once the number of CD34 cells in peripheral blood have reached the minimum to proceed with the collection The minimum number of CD34 cells needed to carry out the transplant will be determined at the discretion of each site although a minimum of 2 x106 CD34Kg is recommended as well as cryopreservation storage defrosting and infusion of HSCs If mobilization fails using G-CSF alone the recommended action is to utilize plerixafor during the same procedure in order to save this time Sites should administer plerixafor in accordance with their own established procedures If this second attempt fails the site can proceed to a third mobilization attempt using cyclophosphamide plus G-CSF
Consolidation Cycles 6-8
At day 90 after autologous stem cell transplant patients will receive consolidation treatment with 1 additional cycle of belantamab mafodotin 2 additional cycles of VRd following the same scheme as in the induction
Belantamab mafodotin will be administered at the dose of 25 mgkgevery 8 weeks on day 1 intravenously
Bortezomib will be given subcutaneously at 13 mgm2 on days 1 4 8 and 11 of every 28-day cycle
Lenalidomide will be given as an oral drug in the dose of 25 mgday on days 1-21
Dexamethasone will be given as an oral drug at the dose of 20 mg on days 1 2 4 5 8 9 11 and 12 of every 28-day cycle
Maintenance
After completion of the consolidation treatment all the responding patients will receive maintenance treatment with Lenalidomide 10 mgday belantamab mafodotin 25 mgkgevery 8 weeks intravenously Lenalidomide will be administered continuously until disease progression patient withdrawal unacceptable toxicity loss to follow up end of study or death Belantamab mafodotin will be administered for 2 years until disease progression patient withdrawal loss to follow up unacceptable toxicity end of study or death
The trial has the following objectives
Objectives
Primary objective
To evaluate the safety and tolerability of the combination of belantamab mafodotin VRd in newly diagnosed transplant eligible multiple myeloma patients
Secondary objectives To assess the efficacy of belantamab mafodotin in combination with VRd in terms of response rate focusing on complete response and MRD
Efficiency of hematopoietic stem cell collection after 2 induction cycles of treatment of belantamab mafodotin 4 induction cycles of treatment of VRd
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002050-24 | EUDRACT_NUMBER | None | None |