A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)–DREAMM5.

Conditions

Multiple Myeloma

Brief summary

Dose Exploration: • Percentage (number) of participants with DLTs, Dose Exploration: • Percentage of participants with AEs, changes in clinical signs and laboratory parameters, Cohort Expansion: • ORR, according to the IMWG Response Criteria [Kumar, 2016]

Detailed description

Key Secondary end point Dose Exploration: • Clinical activity measured as ORR, according to IMWG Response Criteria, Secondary End points Dose Exploration: Rates of PR, VGPR, CR, sCR, Belantamab mafodotin observed concentrations, Anticancer combination observed concentrations, Incidence and titers of ADAs against belantamab mafodotin & combination treatments, Incidence of AEs of special interest for belantamab mafodotin and combination treatments, Incidence of ocular findings on ophthalmic exam, Secondary end points Cohort Expansion: CBR according to the IMWG Response Criteria [Kumar, 2016], PFS, DoR, TTR, Rates of: PR, VGPR; CR, sCR, OS, Incidence of AEs, SAEs, AEs leading to discontinuation or dose reduction/delay, changes in clinical signs, and laboratory parameters., Incidence of AESIs for belantamab mafodotin., Incidence of AESIs for the individual partner for each sub-study., Incidence of ocular findings on ophthalmic exam for belantamab mafodotin., Belantamab mafodotin and combination treatment’s plasma concentrations, Incidence and titers of ADAs against belantamab mafodotin and combination treatments, when measured

Related papers

No related papers found yet.

Interventions

DRUGIsatuximab

DRUGDexa-ratiopharm® 8 mg Injektionslösung

DRUGFortecortin® 2 mg Tabletten

DRUGRevlimid 15 mg hard capsules

DRUGZelvina 2.5 mg hard capsules

DRUGRevlimid 10 mg hard capsules

DRUGRevlimid 2.5 mg hard capsules

DRUGZelvina 5 mg hard capsules

DRUGZelvina 25 mg hard capsules

DRUGImnovid 2 mg hard capsules

DRUGImnovid 3 mg hard capsules

DRUGZelvina 10 mg hard capsules

DRUGRevlimid 25 mg hard capsules

DRUGImnovid 1 mg hard capsules

DRUGDexamethason 8 mg GALEN® Tabletten

DRUGNirogacestat

DRUGDexa 8 mg inject JENAPHARM Injektionslösung

DRUGRevlimid 5 mg hard capsules

DRUGDexamethason 8 mg JENAPHARM®

DRUGImnovid 4 mg hard capsules

DRUGZelvina 15 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose Exploration: • Percentage (number) of participants with DLTs, Dose Exploration: • Percentage of participants with AEs, changes in clinical signs and laboratory parameters, Cohort Expansion: • ORR, according to the IMWG Response Criteria [Kumar, 2016]	—

Secondary

Measure	Time frame
Key Secondary end point Dose Exploration: • Clinical activity measured as ORR, according to IMWG Response Criteria, Secondary End points Dose Exploration: Rates of PR, VGPR, CR, sCR, Belantamab mafodotin observed concentrations, Anticancer combination observed concentrations, Incidence and titers of ADAs against belantamab mafodotin & combination treatments, Incidence of AEs of special interest for belantamab mafodotin and combination treatments, Incidence of ocular findings on ophthalmic exam, Secondary end points Cohort Expansion: CBR according to the IMWG Response Criteria [Kumar, 2016], PFS, DoR, TTR, Rates of: PR, VGPR; CR, sCR, OS, Incidence of AEs, SAEs, AEs leading to discontinuation or dose reduction/delay, changes in clinical signs, and laboratory parameters., Incidence of AESIs for belantamab mafodotin., Incidence of AESIs for the individual partner for each sub-study., Incidence of ocular findings on ophthalmic exam for belantamab mafodotin., Belantamab mafodotin and com	—

Measure

Time frame

Key Secondary end point Dose Exploration: • Clinical activity measured as ORR, according to IMWG Response Criteria, Secondary End points Dose Exploration: Rates of PR, VGPR, CR, sCR, Belantamab mafodotin observed concentrations, Anticancer combination observed concentrations, Incidence and titers of ADAs against belantamab mafodotin & combination treatments, Incidence of AEs of special interest for belantamab mafodotin and combination treatments, Incidence of ocular findings on ophthalmic exam, Secondary end points Cohort Expansion: CBR according to the IMWG Response Criteria [Kumar, 2016], PFS, DoR, TTR, Rates of: PR, VGPR; CR, sCR, OS, Incidence of AEs, SAEs, AEs leading to discontinuation or dose reduction/delay, changes in clinical signs, and laboratory parameters., Incidence of AESIs for belantamab mafodotin., Incidence of AESIs for the individual partner for each sub-study., Incidence of ocular findings on ophthalmic exam for belantamab mafodotin., Belantamab mafodotin and com

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Countries

France, Norway, Poland, Sweden

Outcome results

None listed