Ixazomib Plus Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02119468|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2014
Last Update Posted : April 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Refractory Plasma Cell Myeloma Recurrent Plasma Cell Myeloma||Drug: ixazomib citrate Drug: dexamethasone Drug: pomalidomide Other: laboratory biomarker analysis||Phase 1 Phase 2|
I. To determine the recommended phase II dose (RP2D) of MLN9708 (ixazomib), when given in combination with pomalidomide and dexamethasone, in patients with relapsed or relapsed/refractory multiple myeloma. (Phase I) II. To estimate the response rate and to evaluate the antitumor activity of the three drug combination: MLN9708 (at the RP2D), pomalidomide and dexamethasone, in patients with relapsed or relapsed/refractory multiple myeloma. (Phase II)
I. To evaluate the safety of MLN9708 at each dose level when given as part of a three drug combination by assessing the following: type, frequency, severity, attribution, time course and duration of adverse events; and clinical laboratory tests at various points in the study. (Phase I) II. To characterize and evaluate toxicities, including type, frequency, severity, attribution, time course and duration, at the RP2D, for the three drug combination. (Phase II) III. To obtain estimates of response duration, depth of response, clinical benefit response, and survival (overall and progression-free), at the RP2D, for the three drug combination. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of ixazomib followed by a phase II study.
Patients receive ixazomib orally (PO) on days 1, 8, and 15; dexamethasone PO on days 1, 8, 15, and 22; and pomalidomide PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of MLN9708 Plus Pomalidomide and Dexamethasone for Relapsed or Relapsed Refractory Multiple Myeloma|
|Study Start Date :||June 30, 2014|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: Treatment (ixazomib citrate, dexamethasone, pomalidomide)
Patients receive ixazomib orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: ixazomib citrate
Other Names:Drug: dexamethasone
Other Names:Drug: pomalidomide
Other Names:Other: laboratory biomarker analysis
- Toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.03 (Phase I) [ Time Frame: Up to 28 days ]The highest dose level that produces 1/6 dose-limiting toxicities (DLTs) in course 1 will be the maximum tolerated dose (MTD). The RP2D of ixazomib and pomalidomide will generally be the MTD, but it may be less than the MTD based on a review of available data/cumulative toxicities from phase I.
- Response rate (confirmed stringent complete remission [sCR]/complete remission [CR]/very good partial remission [VGPR] or partial remission [PR]), based on the IMWG criteria (Phase II) [ Time Frame: Up to 24 months ]Response rates (overall, clinical benefit) and depth of response will be calculated as the percent of evaluable patients that have confirmed sCR/CR/VGPR or PR (overall) or sCR/CR/VGPR/PR/minimal response (MR) or stable disease (SD) (clinical benefit), exact 95% confidence intervals will be calculated for these estimates. Response rates will also be evaluated based on number and type of prior therapy(ies).
- Duration of response (Phase II) [ Time Frame: Time interval from the date of first documented response (sCR/CR/VGPR or PR) to documented disease relapse, progression or death whichever occurs first, up to 24 months ]This will be estimated using the product-limit method of Kaplan and Meier.
- Clinical benefit response, based on the IMWG criteria, calculated as the number of responders plus those with a minimal response (MR) or stable disease (SD) divided by the number of evaluable patients (Phase II) [ Time Frame: Up to 24 months ]
- Overall survival (Phase II) [ Time Frame: Date of first dose of study drug to date of death from any cause, up to 24 months ]This will be estimated using the product-limit method of Kaplan and Meier.
- Progression-free survival (Phase II) [ Time Frame: Date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first, up to 24 months ]This will be estimated using the product-limit method of Kaplan and 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): NCT02119468
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|United States, Georgia|
|Emory University/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Tennessee|
|Sarah Cannon Research Institute (SCRI)|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Amrita Krishnan||City of Hope Medical Center|