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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Ixazomib capsules.
Thalidomide capsules.
Dexamethasone tablets.
CEHON Centro de Hematologia e Oncologia da Bahia
Salvador, Estado de Bahia, Brazil
Instituto COI de Educacao e Pesquisa
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Estadual de Campinas UNICAMP - HEMOCENTRO
Campinas, São Paulo, Brazil
ORR During Induction
ORR is the percentage of participants with presence of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). ORR assessment will be based on International Myeloma Working Group (IMWG) response criteria.
Time frame: Upon ORR assessment during specific timepoints for all participants completing or withdrawn prematurely from the induction phase (Baseline up to approximately 9 month [Cycle 9])
Progression-free Survival (PFS)
PFS is the time elapsed between treatment initiation and first PD documentation or death from any cause, where PD is assessed by IMWG response criteria.
Time frame: Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 2 years])
ORR During Maintenance
ORR is the percentage of participants with presence of sCR, CR, VGPR or PR. ORR assessment will be based on IMWG response criteria.
Time frame: Upon ORR assessment during specific time points for all participants completing or withdrawn prematurely from maintenance phase (Baseline up to approximately 2 years)
Overall Survival (OS)
OS is defined as the time elapsed between treatment initiation and death from any cause.
Time frame: Upon study termination (Baseline up to approximately 5 years)
Time to Response During Induction
Time to response is the time elapsed between treatment initiation and the first documentation of sCR, VGPR or PR according to the IMWG response criteria.
Time frame: End of induction phase (Baseline up to approximately 9 months [Cycle 9])
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Clinica Medica Sao Germano S/S Ltda.
São Paulo, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil