Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT03227432
Status:
WITHDRAWN
Last Update Posted:
2018-08-14
First Post:
2017-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn before enrollment due to issues around the FDA hold on PD-1/PD-L1 drugs in combination with IMIDs.
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 studying a combination of targeted therapies as a possible treatment for multiple myeloma (MM).
The drugs involved in this study are:
* Elotuzumab
* Nivolumab
* Pomalidomide
* Dexamethasone
The drugs involved in this study are:
* Elotuzumab
* Nivolumab
* Pomalidomide
* Dexamethasone
Detailed Description:
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 combination works in treating a specific disease. "Investigational" means that the drug combination is being studied.
This study has two parts. Each part tests a different combination of drugs.
* In Part 1 participants will be given elotuzumab and nivolumab.
* In Part 2 participants will be given elotuzumab, nivolumab, pomalidomide, and dexamethasone.
Each of these drugs works in a different way to help the body fight multiple myeloma. The drugs are being tested in different combinations to see if they are more effective when taken together.
Elotuzumab is an antibody, that stimulates the immune system to fight your disease. The FDA (the U.S. Food and Drug Administration) has approved elotuzumab in combination with lenalidomide as a treatment option for this disease.
In this research study, the participant will receive pomalidomide which is an immunomodulatory drug. This means that pomalidomide modulates the immune system to help fight the disease. The FDA has approved pomalidomide as a treatment option for this disease after receiving two other therapies.
Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias.
The FDA has not approved nivolumab for this specific disease but it has been approved for other uses, specifically lung cancer. Nivolumab works by blocking an inhibitory signal within immune cells, potentially allowing the immune system to fight the cancer.
In this research study the investigators are looking to see if the combination of elotuzumab, nivolumab, pomalidomide, and dexamethasone is effective in fighting the cancer.
This study has two parts. Each part tests a different combination of drugs.
* In Part 1 participants will be given elotuzumab and nivolumab.
* In Part 2 participants will be given elotuzumab, nivolumab, pomalidomide, and dexamethasone.
Each of these drugs works in a different way to help the body fight multiple myeloma. The drugs are being tested in different combinations to see if they are more effective when taken together.
Elotuzumab is an antibody, that stimulates the immune system to fight your disease. The FDA (the U.S. Food and Drug Administration) has approved elotuzumab in combination with lenalidomide as a treatment option for this disease.
In this research study, the participant will receive pomalidomide which is an immunomodulatory drug. This means that pomalidomide modulates the immune system to help fight the disease. The FDA has approved pomalidomide as a treatment option for this disease after receiving two other therapies.
Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias.
The FDA has not approved nivolumab for this specific disease but it has been approved for other uses, specifically lung cancer. Nivolumab works by blocking an inhibitory signal within immune cells, potentially allowing the immune system to fight the cancer.
In this research study the investigators are looking to see if the combination of elotuzumab, nivolumab, pomalidomide, and dexamethasone is effective in fighting the cancer.
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?: