Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02916771|
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Smoldering Multiple Myeloma||Drug: Ixazomib Drug: Lenalidomide Drug: Dexamethasone||Phase 2|
This research study is a Phase II clinical trial, which tests the effectiveness of an investigational drug(s). The investigational drugs used in this research study are Ixazomib, Lenalidomide and Dexamethasone.
"Investigational" means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of Ixazomib, Lenalidomide and Dexamethasone as a treatment regimen for Smoldering Multiple Myeloma. The purpose of this research study is to learn whether the combination of Ixazomib, Lenalidomide, and Dexamethasone works in treating Smoldering Multiple Myeloma.
Ixazomib is a drug that may kill or stop cancer cells from growing by blocking the proteasome within the cell, which is responsible for degrading or breaking down a variety of proteins. This type of drug is called a proteasome inhibitor. Lenalidomide is an immunomodulatory drug, meaning it modifies the participant immune system to help fight the participant disease. Dexamethasone is a steroid, which is usually combined with other drugs to enhance their effects to fight the participant disease.
Ixazomib is approved by the FDA in combination with Lenalidomide and Dexamethasone for the treatment of Multiple Myeloma and is currently being evaluated for use in the treatment of several types of cancers. Both Lenalidomide and Dexamethasone have been previously approved by the FDA for the treatment of Multiple Myeloma, as well as several other cancers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2024|
Oral, proteasome inhibitor
Other Name: Ninlaro
Oral, immunomodulatory agent
Other Name: Revlimid
Other Name: Decadron
- Proportion Of High Risk SMM Patients Who Are Progression Free 2 Years After Receiving IRD Combination Therapy [ Time Frame: 2 years ]The proportion of patients who achieve progression free at 2 years will be compared to the rate published for the high risk SMM. By the Mayo Clinic model for risk factors, the median time to progression for patients with high risk SMM was only 1.9 years. Therefore, we assume that, a 2-years progression-free rate of 50% will not be considered promising and a true progression free rate of 75% or higher will be considered promising.
- Progression Free Survival [ Time Frame: Time from protocol therapy initiation to the disease progression or death from any cause, censored at date last known progression free for those who have not progressed or died, or up to 60 months post initiation of therapy ]Progression-free survival is defined as the time from protocol therapy initiation to the disease progression or death from any cause, censored at date last known progression free for those who have not progressed or died
- Time To Progression [ Time Frame: The time from protocol therapy initiation until documented progression, censored at date last known progression-free for those who have not progressed or up to 60 months post initiation of therapy ]Time to progression (TTP) is defined as the time from protocol therapy initiation until documented progression, censored at date last known progression-free for those who have not progressed.
- Duration of Response [ Time Frame: time from objective response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died, or up to 60 months post initiation of therapy ]Duration of response is defined as the time from objective response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died
- Objective Response Rate [ Time Frame: 2 years ]The objective response rate is defined as partial response or better according to the modified IMWG criteria and the proportion of patients with a MRD, CR, PR or MR will be reported with 90% exact binominal confidence interval (CI)
- Overall Survival [ Time Frame: Time from protocol therapy initiation to death or date last known alive, or up to 60 months post initiation of treatment ]Overall survival is defined as the time from protocol therapy initiation to death or date last known alive
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): NCT02916771
|Contact: Alexandra Savellfirstname.lastname@example.org|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Irene M Ghobrial, MD 617-632-4198 Irene_Ghobrial@dfci.harvard.edu|
|Principal Investigator: Irene M Ghobrial, MD|
|Principal Investigator:||Irene M Ghobrial, MD||Dana-Farber Cancer Institute|