Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-01-10 @ 1:49 AM
Study NCT ID:
NCT03657420
Status:
WITHDRAWN
Last Update Posted:
2019-08-14
First Post:
2018-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of ABI-009 (Nab-rapamycin) in Combination With Pomalidomide and Dexamethasone for Relapsed and Refractory Multiple Myeloma
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Phase Ib Investigation of the Safety and Efficacy of ABI-009 (Nab-rapamycin) in Combination With Pomalidomide and Dexamethasone for Relapsed and Refractory Multiple Myeloma
Status:
WITHDRAWN
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding withdrawn by sponsor
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 drugs as a possible treatment for multiple myeloma.
The drugs that will be administered are:
* ABI-009 (nab-rapamycin)
* Pomalidomide
* Dexamethasone
The drugs that will be administered are:
* ABI-009 (nab-rapamycin)
* Pomalidomide
* Dexamethasone
Detailed Description:
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved ABI-009 as a treatment for any disease.
The FDA has approved pomalidomide and dexamethasone as treatment options for multiple myeloma.
The purpose of this study is to determine whether ABI-009 (study drug) will be safe and slow the progress of the disease when used in combination with pomalidomide and dexamethasone, depending on what type of cancer.
ABI-009 is an inhibitor of an overactive biological pathway in the cancer cells. Pomalidomide is an immunomodulatory agent and believed to work by affecting the growth signals that keep cancer cells alive. Dexamethasone is a steroid which is believed to kill cancer cells. The investigators hope that the combination of ABI-009 with pomalidomide and dexamethasone will help stop the growth of the cancer.
The FDA (the U.S. Food and Drug Administration) has not approved ABI-009 as a treatment for any disease.
The FDA has approved pomalidomide and dexamethasone as treatment options for multiple myeloma.
The purpose of this study is to determine whether ABI-009 (study drug) will be safe and slow the progress of the disease when used in combination with pomalidomide and dexamethasone, depending on what type of cancer.
ABI-009 is an inhibitor of an overactive biological pathway in the cancer cells. Pomalidomide is an immunomodulatory agent and believed to work by affecting the growth signals that keep cancer cells alive. Dexamethasone is a steroid which is believed to kill cancer cells. The investigators hope that the combination of ABI-009 with pomalidomide and dexamethasone will help stop the growth of 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?: