Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

PHASE2RecruitingINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

December 1, 2022

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Myeloma Multiple
Interventions
DRUG

Belantamab mafodotin

"Belantamab Mafodotin~Belantamab mafodotin dose levels:~Dose level -2 = 1.4 mg/kg IV every 12 weeks Dose level -1 = 1.9 mg/kg IV every 12 weeks Dose level 0 = 1.9 mg/kg IV every 8 weeks~Cycles 1 - 6:~All patients will start at dose level 0.~Cycles 7 and onwards\*:~Patients previously on dose level 0 (1.9 mg/kg IV every 8 weeks) will change to dose level -1 (1.9 mg/kg IV every 12 weeks) Patients previously on dose level -1 (1.9 mg/kg IV every 12 weeks) will continue at the same dose level.~Patients previously on dose level -2 (1.4 mg/kg IV every 12 weeks) will continue at the same dose level.~\*Reduction to a lower dose level is allowed in case of development of adverse effects or poor tolerance as determined by the treating physician."

DRUG

Lenalidomide

"Lenalidomide dose levels:~Dose level 0 (starting dose): Lenalidomide 10 mg/day PO continuously. Dose level -1: Lenalidomide 10 mg/day PO. One week off after every three weeks of treatment.~Dose level -2: Lenalidomide 5 mg/day PO. One week off after every three weeks of treatment."

Trial Locations (1)

77051

RECRUITING

MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER