Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 23, 2023

Primary Completion Date

May 31, 2025

Study Completion Date

December 31, 2029

Conditions
Multiple Myeloma in Relapse
Interventions
DRUG

Elranatamab (PF-06863135)

The scheme of administration includes weekly administrations for at least six 4-weeks cycles and, if patients have achieved at least PR (or better) persisting for at least 2 months, the dose interval should be changed from weekly to every other week. Treatment will be scheduled with a response-adapted duration and patients achieving undetectable measurable residual disease (MRD) and maintained for 12 months will stop therapy. After stopping therapy, and if the patient is in sustained undetectable MRD for at least 12 months, it would be possible to re-start treatment with elranatamab in case the MRD will be detectable or relapse from CR will occur. Patients who will not achieve undetectable MRD sustained for 12 months will receive continuous treatment until progressive disease.

Trial Locations (15)

11407

NOT_YET_RECRUITING

Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera

15706

NOT_YET_RECRUITING

Hospital Clínico Universitario de Santiago ~ CHUS, Santiago de Compostela

28041

NOT_YET_RECRUITING

Instituto de Investigación Sanitaria Hospital 12 de Octubre, Madrid

28050

NOT_YET_RECRUITING

Hospital HM Sanchinarro, PAU de Sanchinarro

30120

NOT_YET_RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar

31008

NOT_YET_RECRUITING

Clinica Universidad Navarra (CUN), Pamplona

33394

RECRUITING

Hospital de Cabueñes, Gijón

35010

NOT_YET_RECRUITING

CHU de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria

37007

RECRUITING

Hospital Clínico Universitario Salamanca, Salamanca

39008

NOT_YET_RECRUITING

Hospital Universitario Marqués de Valdecilla, Santander

45005

NOT_YET_RECRUITING

C.H. de Toledo (Virgen de la Salud), Toledo

07198

NOT_YET_RECRUITING

Hospital Son Llàtzer, Palma de Mallorca

08916

NOT_YET_RECRUITING

Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol, Badalona

08908

NOT_YET_RECRUITING

Institut Catala d'Oncologia (ICO) Hospital Duran i Reynals, L'Hospitalet de Llobregat

08036

NOT_YET_RECRUITING

H. Clínic i Provincial de Barcelona, Barcelona

All Listed Sponsors
lead

PETHEMA Foundation

OTHER