Safety and Efficacy of ABI-009 (Nab-rapamycin) in Combination With Pomalidomide and Dexamethasone for Relapsed and Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03657420|
Recruitment Status : Withdrawn (Funding withdrawn by sponsor)
First Posted : September 5, 2018
Last Update Posted : August 14, 2019
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)
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: ABI-009 Drug: Pomalidomide Drug: Dexamethasone||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||May 30, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: ABI-009 + Pomalidomide + Dexamethasone
ABI-009 is an mTOR inhibitor. This pathway is believed to be overactive in multiple myeloma.
Other Name: nab-rapamycin
Pomalidomide is an immunomodulatory agent and believed to work by affecting the growth signals that keep cancer cells alive.
Other Name: Pomalyst
Dexamethasone is a steroid which is believed to kill cancer cells
Other Name: Decadron
- Maximum tolerated dose. [ Time Frame: 1 Cycle (28-Days) ]The maximum Tolerated Dose (MTD) is the highest dose of ABI-009 (nab-rapamycin) when administered in combination with pomalidomide and dexamethasone that dose not cause unacceptable side effects. The maximum tolerated dose is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found. A standard 3+3 dose escalation design will be used to assess the MTD.
- Overall response rate. [ Time Frame: 2 years ]The number of participants that achieve a partial response or better. This is assessed using International Myeloma Working Group criteria.
- Progression free survival. [ Time Frame: 2 years ]Progression free survival is defined as the time to disease progression or death from any cause, censored at date last known progression free for those who have not progressed or died. Progression is assessed using International Myeloma Working Group Criteria.
- Treatment-emergent adverse events. [ Time Frame: 2 years ]Adverse events will be assessed using CTCAE criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657420
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Andrew J. Yee, MD||Massachusetts General Hospital|