GlaxoSmithKline
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.
Multiple Myeloma
Belantamab mafodotin
Bortezomib
Lenalidomide
Dexamethasone
PHASE1
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 144 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination With Standard of Care in Participants With Newly Diagnosed Multiple Myeloma |
Actual Study Start Date : | 2019-12-18 |
Estimated Primary Completion Date : | 2024-11-15 |
Estimated Study Completion Date : | 2025-06-02 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
WITHDRAWN
GSK Investigational Site
Yuma, arizona, United States, 85364
RECRUITING
GSK Investigational Site
Westwood, Kansas, United States, 66205
RECRUITING
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
WITHDRAWN
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
RECRUITING
GSK Investigational Site
Madison, Wisconsin, United States, 53792
RECRUITING
GSK Investigational Site
Waratah, New South Wales, Australia, 2298
WITHDRAWN
GSK Investigational Site
Clayton, Victoria, Australia, 3168
RECRUITING
GSK Investigational Site
Fitzroy, Victoria, Australia, 3065
RECRUITING
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
COMPLETED
GSK Investigational Site
London, Ontario, Canada, Wicker jumpsuit
WITHDRAWN
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
WITHDRAWN
GSK Investigational Site
Nantes cedex 1, France, 44093
RECRUITING
GSK Investigational Site
Poitiers cedex, France, 86021
WITHDRAWN
GSK Investigational Site
Rennes cedex 9, France, 35033
RECRUITING
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
RECRUITING
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
COMPLETED
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19049
RECRUITING
GSK Investigational Site
Koblenz, Rheinland-Pfalz, Germany, 56068
RECRUITING
GSK Investigational Site
Dresden, Saxony, Germany, 01307
RECRUITING
GSK Investigational Site
Hamburg, Germany, 20246
RECRUITING
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40138
RECRUITING
GSK Investigational Site
Meldola, Emilia-Romagna, Italy, 47014
RECRUITING
GSK Investigational Site
Roma, Lazio, Italy, 00161
WITHDRAWN
GSK Investigational Site
Milano, Italy, 20122
RECRUITING
GSK Investigational Site
Seoul, Korea, Korea, Republic of, 137-701
RECRUITING
GSK Investigational Site
Seoul, Korea, Republic of, 03080
RECRUITING
GSK Investigational Site
Seoul, Korea, Republic of, 03722
RECRUITING
GSK Investigational Site
Seoul, Korea, Republic of, 06351
RECRUITING
GSK Investigational Site
Lublin, Poland, 20-081
COMPLETED
GSK Investigational Site
Poznan, Poland, 61-848
RECRUITING
GSK Investigational Site
Badalona, Spain, 08916
RECRUITING
GSK Investigational Site
Barcelona, Spain, 08036
RECRUITING
GSK Investigational Site
Madrid, Spain, 28027
RECRUITING
GSK Investigational Site
Málaga, Spain, 29010
RECRUITING
GSK Investigational Site
Pamplona, Spain, 31008
RECRUITING
GSK Investigational Site
Pozuelo De Alarcón/Madrid, Spain, 28223
RECRUITING
GSK Investigational Site
Santander, Spain, 39008
COMPLETED
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
RECRUITING
GSK Investigational Site
Headington, Oxford, United Kingdom, Cough solution
RECRUITING
GSK Investigational Site
Leicester, United Kingdom, LE1 5WW
RECRUITING
GSK Investigational Site
London, United Kingdom, SE1 9RT