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Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)

Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab

Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation

Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation

Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab

Daratumumab 16mg/kg every 8 weeks for 2 years

Philippe Moreau, Pr

The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.

This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 2-arm (2 treatment groups), multicenter study of daratumumab in participants diagnosed with previously untreated Multiple Myeloma who are eligible for high dose chemotherapy and autologous stem cell transplantation (transplantation of own bone marrow). Participants will be randomized (assigned by chance) to one of 2 treatment groups to either receive daratumumab plus bortezomib, thalidomide and dexamethasone or bortezomib, thalidomide and dexamethasone for induction (before transplantation) and consolidation (after transplantation) treatment. All responders will then be re-randomized (assigned by chance) to one of 2 treatment groups to receive maintenance treatment with daratumumab only or observation (no treatment). The study will include a 28-Day Screening Phase, a Treatment Phase of 6 treatment cycles (each cycle is 4 weeks in duration for total period of 30 weeks), and a Follow up Phase of 2 years. The total duration for each participant in the study will be approximately 138 weeks. The end of the study will occur approximately 5 years after the last participant is randomized in the second phase of the study. Disease assessments will be performed every 4 weeks in the first phase of the study and then every 8 weeks in the second phase of the study. Safety will be monitored throughout the study.

A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma

sCR is defined by achieving CR (complete response) in addition to having a normal serum FLC (Free Light Chain) ratio and absence of clonal cells in bone marrow

Time from the date of second randomization to either progressive disease (PD) or death

time from the initial randomization to either confirmed progressive disease (PD) or death

Time from the initial randomization to confirmed progressive disease (PD) or death due to progressive disease

Proportion of participants who have achieved CR or sCR by the end of consolidation treatment

proportion of participants who have achieved MRD (minimal residual disease) negative status by the end of consolidation

proportion of participants who have achieved sCR (stringent complete response) prior to high-dose therapy/ASCT (autologous stem cell transplantation)

time from initial randomization to subsequent progression on next-line of therapy after disease progression on study treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma	NCT02541383	Multiple Myelom...	Bortezomib (VEL... Bortezomib, Tha... Daratumumab	18 Years - 65 Years	Intergroupe Francophone du Myelome
A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma	NCT02541383	Multiple Myelom...	Bortezomib (VEL... Bortezomib, Tha... Daratumumab	18 Years - 65 Years	Intergroupe Francophone du Myelome

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