Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06282978
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-11-23
Brief Title:
Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
An Open Label Multicenter Phase II Study of Elranatamab as Single Agent for the Treatment of Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes GEM-RANTAB
Status:
RECRUITING
Status Verified Date:
2024-02
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:
The goal of this phase II open-label single-arm multicenter study is to evaluate i the efficacy and ii safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs protease inhibitors and anti-CD38 therapy and were refractory to the last line of therapy defined as progression while receiving treatment or in the first 60 days after the last dose of treatment
Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group IMWG criteria evaluated by the investigators
Safety refers to the measurement of
i Adverse events AEs and serious adverse events SAEs according to standard clinical and laboratory tests hematology and chemistry physical examination vital sign measurements and diagnostic tests
ii Incidence and severity of Cytokine Release Syndrome CRS and Immune effector cell associated neurotoxicity syndrome ICANS according to the American Society for Transplantation and Cellular Therapy ASTCT criteria
iii Incidence and severity of other neurotoxicities iv Incidence of cytopenias and infections
The study consists of a screeningbaseline period a treatment period and a posttreatment follow-up period The study includes a periodic review of safety data that will be independently analyzed by the Data Safety Independent Committee DSMC and will recommend how to proceed with the study
Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group IMWG criteria evaluated by the investigators
Safety refers to the measurement of
i Adverse events AEs and serious adverse events SAEs according to standard clinical and laboratory tests hematology and chemistry physical examination vital sign measurements and diagnostic tests
ii Incidence and severity of Cytokine Release Syndrome CRS and Immune effector cell associated neurotoxicity syndrome ICANS according to the American Society for Transplantation and Cellular Therapy ASTCT criteria
iii Incidence and severity of other neurotoxicities iv Incidence of cytopenias and infections
The study consists of a screeningbaseline period a treatment period and a posttreatment follow-up period The study includes a periodic review of safety data that will be independently analyzed by the Data Safety Independent Committee DSMC and will recommend how to proceed with the study
Detailed Description:
Treatment with elranatamab will be initiated using a 2-step-up priming regimen the initial doses of elranatamab will be 12 mg Cycle 1 Day 1 and 32 mg Cycle1 Day 4 Participants should be hospitalized and monitored for toxicity especially CRSICANS for at least 2 days 48 hours beginning on Cycle 1 Day 1 and for 1 day 24 hours for Cycle1 Day 4 The dose of elranatamab should be increased to 76 mg on Cycle 1 Day 8 as long as the participant meets the redosing criteria or deferred until the criteria are met
The scheme of administration includes weekly administrations for at least six 4-weeks cycles and if patients have achieved at least PR or better persisting for at least 2 months the dose interval should be changed from weekly to every other week Treatment will be scheduled with a response-adapted duration and patients achieving undetectable measurable residual disease and maintained for 12 months will stop therapy After stopping therapy and if the patient is in sustained undetectable measurable residual disease for at least 12 months it would be possible to re-start treatment with elranatamab in case the measurable residual disease will be detectable or relapse from CR will occur Patients who will not achieve undetectable measurable residual disease sustained for 12 months will receive continuous treatment until progressive disease In both situations the occurrence of unacceptable toxicity might result into the treatment discontinuation
The scheme of administration includes weekly administrations for at least six 4-weeks cycles and if patients have achieved at least PR or better persisting for at least 2 months the dose interval should be changed from weekly to every other week Treatment will be scheduled with a response-adapted duration and patients achieving undetectable measurable residual disease and maintained for 12 months will stop therapy After stopping therapy and if the patient is in sustained undetectable measurable residual disease for at least 12 months it would be possible to re-start treatment with elranatamab in case the measurable residual disease will be detectable or relapse from CR will occur Patients who will not achieve undetectable measurable residual disease sustained for 12 months will receive continuous treatment until progressive disease In both situations the occurrence of unacceptable toxicity might result into the treatment discontinuation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504273-21 | EUDRACT_NUMBER | None | None |