NCT03608501

A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation

An Open-Label, Single-Arm Phase II Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-Naive Multiple Myeloma Patients Non-Eligible for Autologous Stem-Cell Transplantation

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine the overall response rate (ORR) during induction therapy with the combination of ixazomib, thalidomide and low-dose dexamethasone in specific time points.

Detailed description

The drugs being tested in this study are a combination therapy of ixazomib, thalidomide and low-dose dexamethasone. This combination therapy is being tested to treat people who are newly diagnosed with multiple myeloma and non-eligible to autologous stem cell transplantation (ASCT). This study will assess the ORR during induction therapy in specific timepoints. The study will enroll approximately 40 participants. All participants will receive: Ixazomib citrate 4 mg + Thalidomide 100 mg and Dexamethasone 40 mg. All participants will be asked to take their study medication at approximately the same time each day. This multi-center trial will be conducted in Brazil. The overall time to participate in this study is approximately 5 years. Participants will make multiple visits to the clinic, and will be contacted by telephone or will make a final visit 30 days after receiving their last dose of drug or resolution of serious adverse event (SAE), whichever occurs later for a follow-up assessment.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Ixazomib	Ixazomib capsules.
DRUG	Thalidomide	Thalidomide capsules.
DRUG	Dexamethasone	Dexamethasone tablets.

Timeline

• Start date: 2019-09-30
• Primary completion: 2021-06-30
• Completion: 2023-05-31
• First posted: 2018-08-01
• Last updated: 2020-01-14

Locations

6 sites across 1 country: Brazil