An Effectiveness and Safety Study of Ixazomib in Combination With Lenalidomide and Dexamethasone (IRD) in Participants With Multiple Myeloma (MM) Previously Receiving a Bortezomib-based Induction Regimen (US MM-6)
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|ClinicalTrials.gov Identifier: NCT03173092|
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Ixazomib Drug: Lenalidomide Drug: Dexamethasone||Phase 4|
The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have MM. This study will look at the effectiveness and safety in participants who take ixazomib in addition to lenalidomide and dexamethasone.
The study will enroll approximately 160 participants. Participants will initially receive:
• Ixazomib 4 mg + lenalidomide 25 mg + dexamethasone 40 mg
Participants include MM participants who have received 3 cycles of a bortezomib-based induction regimen (as defined by current National Comprehensive Cancer Network [NCCN] guidelines) and have no evidence of PD following initial first-line therapy. All participants will be asked to take ixazomib 4 mg on Days 1, 8 and 15 and lenalidomide 25 mg from Day 1 through 21 and dexamethasone 40 mg on Days 1, 8, 15 and 22 in 28 day cycles until disease progression or unacceptable toxicity for up to 2 years. Dose modifications of ixazomib, and/or lenalidomide and/or dexamethasone are allowed at the discretion of the physician.
This multi-center trial will be conducted in United States. It is anticipated that the treatment phase of this study will last up to 36 months, including 12 months for enrollment, and a 24-month IRD treatment period (26 cycles) with ixazomib and/or lenalidomide and/or dexamethasone for the last participant enrolled.
Participants will make multiple visits to the clinic as per their standard of care, and will be followed for PFS. After disease progression, participants will be followed-up for overall survival every 6 months until death or termination of the study by the sponsor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) in Patients With Multiple Myeloma Previously Receiving a Bortezomib-Based Induction Regimen (US MM-6)|
|Actual Study Start Date :||September 20, 2017|
|Estimated Primary Completion Date :||November 30, 2023|
|Estimated Study Completion Date :||November 30, 2023|
Experimental: Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Ixazomib 4 milligram (mg), capsules, orally, once, on Days 1, 8 and 15 and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22 of a 28-day cycle for a maximum of 26 cycles until PD or unacceptable toxicity, whichever occurs for up to 2 years.
- Progression Free Survival (PFS) [ Time Frame: From date of first study drug administration until disease progression or death due to any cause, whichever occurs first (Up to 2 years) ]PFS is defined as time from date of first administration of study drug regimen to date of first documentation of progressive disease (PD) based on local laboratory results and investigator's assessment using modified International Myeloma Working Group (IMWG) response criteria or death due to any cause, whichever occurs first.
- Percentage of Participants with Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR) [ Time Frame: Day 1 of each cycle (every 28 days) until disease progression for up to 2 years ]Response is based on investigator's assessment using modified IMWG criteria.
- Duration of Response [ Time Frame: Day 1 of each cycle (every 28 days) until disease progression for up to 2 years ]Duration of response is defined as the time from the date of first documentation of a PR or better to the date of first documentation of PD for responders.
- Duration of Therapy (DoT) [ Time Frame: From the date of the first study drug administration to the date of the last administration of any of the 3 study drugs (Up to 2 years) ]DoT is defined as the time from the date of the first administration of the study drug regimen (IRD) to the date of the last administration of any of the 3 study drugs in the regimen.
- Duration of Ixazomib Therapy [ Time Frame: From the date of the first ixazomib administration to the date of the last ixazomib administration (Up to 2 years) ]Duration of ixazomib therapy is defined as the time from the date of the first administration of ixazomib therapy to the date of the last administration of ixazomib therapy.
- Relative Dose Intensity (RDI) for Each Study Drug [ Time Frame: Up to 2 years ]RDI for each study drug is defined as 100*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals [dose prescribed at enrollment * number of prescribed doses per cycle * the number of treated cycles].
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): NCT03173092
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
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|Study Director:||Medical Monitor Clinical Science||Millennium Pharmaceuticals, Inc.|