Ixazomib + Pomalidomide + Dexamethasone In MM
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|ClinicalTrials.gov Identifier: NCT04094961|
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : January 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Multiple Myeloma in Relapse||Drug: Ixazomib Drug: Pomalidomide Drug: Dexamethasone||Phase 1 Phase 2|
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drug and 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 has approved both pomalidomide and ixazomib individually for the treatment of multiple myeloma. 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.
- Ixazomib targets a part of cells called proteasomes. It works by slowing down or blocking proteasomes from doing their job of digesting proteins. In myeloma cells, there is a greater need for proteasomes to digest proteins; the buildup of excess proteins causes cell death.
- Pomalidomide has also been shown to cause tumor cell deaths. Dexamethasone can stop white blood cells from traveling to areas myeloma cells are causing damage. When combined with myeloma drugs, it sometimes makes those drugs work better.
In this research study, the investigators are:
- Testing the safety of ixazomib when given with pomalidomide and dexamethasone
- Pomalidomide and ixazomib are given individually for the treatment of multiple myeloma. Dexamethasone is also given for multiple myeloma
- Ixazomib when combined with pomalidomide and dexamethasone may help control the disease
- Ixazomib is FDA approved to treat multiple myeloma
- The investigators are looking for the highest dose of ixazomib that can be given safely in combination with pomalidomide and dexamethasone
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Twice Weekly Ixazomib Plus Pomalidomide and Dexamethasone in Relapsed/or Refractory Multiple Myeloma|
|Actual Study Start Date :||September 18, 2019|
|Estimated Primary Completion Date :||March 20, 2022|
|Estimated Study Completion Date :||March 20, 2022|
Experimental: ixazomib plus pomalidomide and dexamethasone
The study drugs will be administered within a 21-day cycle
Oral, administered four times per cycle
Other Name: Ninlaro®
Oral, administered 14 times per cycle
Other Name: Pomalyst®
Oral, fixed dose administered 8 times per cycle
- Number of participants with dose limiting toxicity [ Time Frame: 21 Days ]3 - 24 safety evaluable patients will be enrolled in up to 4 dose levels of ixazomib, pomalidomide and dexamethasone.
- Overall Response Rate [ Time Frame: 28 days ]Response will be evaluated using a Simon optimal two-stage design
- Time to Progression [ Time Frame: time from first dose of study drug to progression, censored at date last known progression-free for those who have not progressed, whichever came first, assessed up to 60 months ]Estimated using the method of Kaplan-Meier.
- Progression Free Survival [ Time Frame: time from first dose of study drug to the disease progression or death from any cause, censored at date last known progression-free for those who have not progressed or died, whichever came first, assessed up to 60 months ]Estimated using the method of Kaplan-Meier.
- Duration of Response [ Time Frame: time from response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died, whichever came first, assessed up to 60 months ]Estimated using the method of Kaplan-Meier.
- Overall Survival [ Time Frame: time from first dose of study drug to death or date last known alive, whichever came first, assessed up to 60 months ]Estimated using the method of Kaplan-Meier.
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): NCT04094961
|Contact: Alexandra Savellfirstname.lastname@example.org|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Paul G Richardson, MD 617-632-2104 Paul_Richardson@dfci.harvard.edu|
|Principal Investigator: Paul G Richardson, MD|
|Principal Investigator:||Paul Richardson, MD||Dana-Farber Cancer Institute|