Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636552
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
An Investigator-Initiated Phase II Multicenter Open-Label Single-Arm Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll L
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Investigator-Initiated Phase II Multicenter Open-Label Single-Arm Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll LEukemIA A Trial of the Greek Myeloma Study Group The EUMELEIA Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EUMELEIA
Brief Summary:
The primary objective of this study is to evaluate the efficacy of the alternating D-PADD-CVD induction regimen followed by D-CVD consolidation regimen and maintenance with daratumumab monotherapy in terms of PFS in the first-line setting of pPCL
Detailed Description:
This is an investigator-initiated prospective multicenter phase II open-label single-arm non-randomized single-stage clinical trial
The study comprises the following phases
A 28-day screening phase An induction phase which includes six 21-day induction treatment cycles of alternating D-PAD and D-CVD starting with D-PAD Note Based on the post-induction treatment disease evaluation transplant-eligible subjects who have achieved SD and PBPC 2 will undergo ASCT whereas those with SD or PBPC 2 will discontinue study treatment Accordingly transplant-eligible subjects who have achieved PR will receive 2 additional D-CVD cycles whereas those with ampltPR will discontinue study treatment
ASCT single or tandem applicable for transplant-eligible patients A consolidation phase which includes two 21-day consolidation cycles of D-CVD A maintenance phase which includes twenty-four 28-day cycles of daratumumab monotherapy applicable for subjects who have achieved PR at the end of consolidation phase Cycle 8 An End of Treatment EOT visit 30 days 7 days after the last dose of all components of the study treatment have been discontinued
A Post-Treatment Follow-Up PTFU phase which will begin once a subject permanently discontinues study treatment In particular
All subjects who complete or discontinue study treatment without disease progression PD will return to the site every 12 weeks 2 weeks for disease evaluation or sooner at Investigators discretion if there are concerns for progressionrelapse and other follow-up assessments until the earliest of confirmed PD start of subsequent therapy for PCL death or the end of study EOS definition is met
After confirmed PD or the start of a new anticancer treatment for PCL subjects will return to the site or be contacted by telephone every 16 weeks 2 weeks for collection of follow-up information ie other malignancies next-line therapy and survival as applicable until death withdrawal of consent for study participation or the EOS definition is met whichever occurs first
The study comprises the following phases
A 28-day screening phase An induction phase which includes six 21-day induction treatment cycles of alternating D-PAD and D-CVD starting with D-PAD Note Based on the post-induction treatment disease evaluation transplant-eligible subjects who have achieved SD and PBPC 2 will undergo ASCT whereas those with SD or PBPC 2 will discontinue study treatment Accordingly transplant-eligible subjects who have achieved PR will receive 2 additional D-CVD cycles whereas those with ampltPR will discontinue study treatment
ASCT single or tandem applicable for transplant-eligible patients A consolidation phase which includes two 21-day consolidation cycles of D-CVD A maintenance phase which includes twenty-four 28-day cycles of daratumumab monotherapy applicable for subjects who have achieved PR at the end of consolidation phase Cycle 8 An End of Treatment EOT visit 30 days 7 days after the last dose of all components of the study treatment have been discontinued
A Post-Treatment Follow-Up PTFU phase which will begin once a subject permanently discontinues study treatment In particular
All subjects who complete or discontinue study treatment without disease progression PD will return to the site every 12 weeks 2 weeks for disease evaluation or sooner at Investigators discretion if there are concerns for progressionrelapse and other follow-up assessments until the earliest of confirmed PD start of subsequent therapy for PCL death or the end of study EOS definition is met
After confirmed PD or the start of a new anticancer treatment for PCL subjects will return to the site or be contacted by telephone every 16 weeks 2 weeks for collection of follow-up information ie other malignancies next-line therapy and survival as applicable until death withdrawal of consent for study participation or the EOS definition is met whichever occurs first
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