A Multi-center, Open-label, Phase 2 Study of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a multicenter, single arm, open-label, Phase 2 study in high risk smoldering myeloma patients. The primary objective is to determine the efficacy of Elranatamab in patients with previously untreated high-risk SMM. The key-secondary objective is to determine the safety of Elranatamab in patients with previously untreated high-risk SMM.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>18 years of age

• Diagnosis of SMM for ≤5 years with measurable disease, defined as serum M protein:

• ≥1g/dL or urine M protein ≥200 mg/24 hours or involved serum FLC ≥100 mg/Land abnormal serum FLC ratio.

• BMPCs ≥10% and \<60%

• Presence of at least 2 high risk factors, including

‣ Serum M protein ≥2 g/dL,

⁃ BMPC \>20%

⁃ Serum involved/uninvolved FLC ratio \> 20

• ECOG performance status score of 0 or 1

• Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1)

‣ Absolute neutrophil count ≥1.0 x 109/L (ie, ≥1000/μL)

⁃ Platelet count ≥75 x 109/L

⁃ Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN)

⁃ Alanine aminotransferase (ALT) ≤2.5 x ULN

⁃ Total bilirubin ≤1.5 x ULN, except in subjects with congenital bilirubinemia,such as Gilbert syndrome (in which case direct bilirubin ≤2.0 x ULN is required)

• Subject must sign an informed consent form (ICF) or their legally acceptable representative must sign indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study.

• Women of childbearing potential must have a negative serum or urine pregnancy test at screening and before starting study drug. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (One highly effective method and one additional effective method) used at the same time, and continuing for at least 5 months after the last dose of Elranatamab. Women must also agree to notify pregnancy during the study.

Locations
Other Locations
Finland
Helsinki University Hospital
NOT_YET_RECRUITING
Helsinki
France
CHD Vendée
RECRUITING
La Roche-sur-yon
CHRU de Lille - Hopital Claude Huriez
NOT_YET_RECRUITING
Lille
CHU Saint Eloi Département d'Hématologie Clinique
RECRUITING
Montpellier
CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE
RECRUITING
Nantes
CHU NICE - Hôpital Archet
RECRUITING
Nice
CHU Poitiers - Pôle régional de Cancérologie
RECRUITING
Poitiers
CHRU Hôpital Bretonneau
RECRUITING
Tours
Greece
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
RECRUITING
Athens
Italy
AOU Consorziale Policlinico di Bari
NOT_YET_RECRUITING
Bari
A.O. Papa Giovanni XXIII
RECRUITING
Bergamo
A.O.U. Careggi
RECRUITING
Florence
A.O.U. Policlinico S. Martino - Ematologia
NOT_YET_RECRUITING
Genova
Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
RECRUITING
Meldola
Ospedale Papardo
RECRUITING
Messina
A.O.U. Maggiore della Carità Novara
RECRUITING
Novara
A.O. di Padova
NOT_YET_RECRUITING
Padua
A.O.U. di Parma - U.O Ematologia e CTMO
NOT_YET_RECRUITING
Parma
Fondazione IRCCS Policlinico S. Matteo
NOT_YET_RECRUITING
Pavia
Ospedale Santo Spirito Ospedale -Azienda Sanitaria Locale Di Pescara
RECRUITING
Roma
Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale
RECRUITING
Udine
Netherlands
Maastricht UMC
RECRUITING
Maastricht
St. Antonius Ziekenhuis
RECRUITING
Nieuwegein
Erasmus MC
RECRUITING
Rotterdam
Norway
Oslo Myeloma Center
RECRUITING
Oslo
Contact Information
Primary
Silvia Villa
silvia.villa@emn.org
+31 107033123
Time Frame
Start Date: 2024-05-14
Estimated Completion Date: 2031-07
Participants
Target number of participants: 50
Treatments
Experimental: Elranatamab
Participant will receive elranatamab subcutaneously (SC) for 24 cycles (28-day cycle)
Sponsors
Collaborators: Pfizer
Leads: Stichting European Myeloma Network

This content was sourced from clinicaltrials.gov