Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma
NCT04091126
Age 18 +
Sex Both
Phase Phase 1
Third Opinion Trial Synopsis
This study is testing a new drug called belantamab mafodotin in combination with three other drugs (Velcade, Revlimid, and dexamethasone) to treat a type of cancer called multiple myeloma. They will test the safety of the new drug and how it works in the body, and figure out the correct amount to use in future studies. Participants will take the four drugs in cycles for eight cycles, then switch to only taking two of the drugs. They will get the new drug at different times depending on their group. After the study, participants will have a follow-up visit to make sure everything is okay.
This study is testing a new drug called belantamab mafodotin in combination with three other drugs (Velcade, Revlimid, and dexamethasone) to treat a type of cancer called multiple myeloma. They will test the safety of the new drug and how it works in the body, and figure out the correct amount to use in future studies. Participants will take the four drugs in cycles for eight cycles, then switch to only taking two of the drugs. They will get the new drug at different times depending on their group. After the study, participants will have a follow-up visit to make sure everything is okay.
Third Opinion AI Generated Synopsis
Trial Summary
This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.
This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.
from ClinicalTrials.gov
Locations & Contact
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