Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT04430894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2020-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
KRDI in Transplant-Eligible MM
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Phase II Study of Once Weekly Carfilzomib, Lenalidomide, Dexamethasone, and Isatuximab in Newly Diagnosed, Transplant-Eligible Multiple Myeloma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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 research study is testing the efficacy of an experimental drug combination for people with newly diagnosed multiple myeloma that are eligible for a stem cell transplant.
The names of the study drugs involved in this study are:
* Carfilzomib
* Isatuximab
* Lenalidomide
* Dexamethasone
The names of the study drugs involved in this study are:
* Carfilzomib
* Isatuximab
* Lenalidomide
* Dexamethasone
Detailed Description:
This is a phase II study to evaluate the efficacy of once weekly carfilzomib, lenalidomide, dexamethasone, and isatuximab (KRDI) in patients with newly diagnosed, transplant-eligible multiple myeloma. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. The study treatment portion of this study is comprised of an induction phase and a maintenance phase.
* Induction Phase :
* All participants will receive the same study drugs (carfilzomib, isatuximab, lenalidomide, and dexamethasone) for up to 8 cycles. Each cycle is 28 days in length.
* All participants will perform stem cell collection after 4 cycles of therapy. Based on the recommendation participants may or may not proceed to an autologous stem cell transplant (SCT) as part of induction therapy.
* Maintenance Phase: During maintenance, participants will receive the study treatment for up to two years after induction until progressive disease or unacceptable toxicity
It is expected that about 50 people will take part in this research study.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease.
"Investigational" means that the drug combination is being studied.
The U.S. Food and Drug Administration (FDA) has approved carfilzomib or isatuximab as a treatment for relapsed/refractory multiple myeloma.
The FDA has also approved lenalidomide and dexamethasone as a treatment option for transplant-eligible multiple myeloma.
However, the FDA has not approved the combination of isatuximab, carfilzomib, lenalidomide, and dexamethasone as an approved regimen. The combination is considered to be investigational for the treatment of individuals with newly diagnosed multiple myeloma.
* Induction Phase :
* All participants will receive the same study drugs (carfilzomib, isatuximab, lenalidomide, and dexamethasone) for up to 8 cycles. Each cycle is 28 days in length.
* All participants will perform stem cell collection after 4 cycles of therapy. Based on the recommendation participants may or may not proceed to an autologous stem cell transplant (SCT) as part of induction therapy.
* Maintenance Phase: During maintenance, participants will receive the study treatment for up to two years after induction until progressive disease or unacceptable toxicity
It is expected that about 50 people will take part in this research study.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease.
"Investigational" means that the drug combination is being studied.
The U.S. Food and Drug Administration (FDA) has approved carfilzomib or isatuximab as a treatment for relapsed/refractory multiple myeloma.
The FDA has also approved lenalidomide and dexamethasone as a treatment option for transplant-eligible multiple myeloma.
However, the FDA has not approved the combination of isatuximab, carfilzomib, lenalidomide, and dexamethasone as an approved regimen. The combination is considered to be investigational for the treatment of individuals with newly diagnosed multiple myeloma.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: