Multiple Myeloma Clinical Trial
Official title:
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
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.
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.
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