Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma

NCT06183489 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EMN34/2023-505775-70-00
• Study Type: interventional
• Target: 50
• Locations: 6 countries
• Sites: 25

Brief 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.

Conditions

Smoldering Multiple Myeloma

Keywords

high-risk smoldering Multiple Myeloma; Elranatamab

Outcome Measures

Primary Outcomes (1)

• Complete Remission (CR) rate

  Response of CR is defined as participants who achieve a CR or better (CR+sCR) according to IMWG response criteria, during the first 6 cycles of treatment and before a possible early termination of the treatment

  average 24 weeks

Secondary Outcomes (9)

• Overall response rate (ORR)

  average 24 weeks

• MRD-negative CR (MRD_CR)

  average 24 weeks

• Progression-free survival (PFS)

  time from the date of 1st dose to to the date of disease progression or death, assed up to 4 years after last dose

• Time to progression (TTP)

  time from the date of 1st dose to progression or death, assed up to 4 years after last dose

• Progression free survival 2 (PFS2)

  time from the date of 1st dose to progression on the next line of treatment or death,assed up to 4 years after last dose

Study Arms (1)

Elranatamab

EXPERIMENTAL

Participant will receive elranatamab subcutaneously (SC) for 24 cycles (28-day cycle)

Drug: Elranatamab

Interventions

Elranatamab DRUG

Elranatamab will be administered via a subcutaneous injection (SC)

Elranatamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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)

You may not qualify if:

• Previous therapy with any systemic therapy for multiple myeloma.
• Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement):
• Increased calcium levels: Corrected serum calcium \>1 mg/dL above the ULN or \>11 mg/dL
• Renal insufficiency: Determined by glomerular filtration rate (GFR) \<40 mL/min/1.73 m² (Modification of Diet in Renal Disease \[MDRD\] Formula) or serum creatinine \>2 mg/dL
• Anemia (hemoglobin 2 g/dL below lower limit of normal or \<10 g/dL or both) transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted
• ≥ 1 bone lytic lesion
• BMPCs ≥60%
• Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L
• Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography-computed tomography (PET-CT) with more than 1 bone focal lesion (≥5 mm in diameter)
• Diagnosis of primary amyloidosis, POEMS syndrome, monoclonal gammopathy of undetermined significance, symptomatic multiple myeloma, or solitary plasmacytoma.
• Subject has a diagnosis of Waldenström's macroglobulinemia, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
• Subject has had plasmapheresis within 14 days of elegibility confirmation.
• Myocardial infarction within 6 months prior to enrolment according to NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• Ongoing Grade 2 or higher peripheral sensory/motor peripheral neuropathy (PN), history of GBS or GBS variants, or history of grade 3 or higher peripheral motor polyneuropathy
• Subject has had major surgery within 2 weeks before elegibility confirmation or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study.

Sponsors & Collaborators

• Stichting European Myeloma Network: lead
• Pfizer: collaborator

Study Sites (25)

Helsinki University Hospital

Helsinki, Finland

NOT YET RECRUITING

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

CHRU de Lille - Hopital Claude Huriez

Lille, France

NOT YET RECRUITING

CHU Saint Eloi Département d'Hématologie Clinique

Montpellier, France

RECRUITING

CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE

Nantes, France

RECRUITING

CHU NICE - Hôpital Archet

Nice, France

RECRUITING

CHU Poitiers - Pôle régional de Cancérologie

Poitiers, France

RECRUITING

CHRU Hôpital Bretonneau

Tours, France

RECRUITING

Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

Athens, Greece

RECRUITING

AOU Consorziale Policlinico di Bari

Bari, Italy

NOT YET RECRUITING

A.O. Papa Giovanni XXIII

Bergamo, Italy

RECRUITING

A.O.U. Careggi

Florence, Italy

RECRUITING

A.O.U. Policlinico S. Martino - Ematologia

Genova, Italy

NOT YET RECRUITING

Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, Italy

RECRUITING

Ospedale Papardo

Messina, Italy

RECRUITING

A.O.U. Maggiore della Carità Novara

Novara, Italy

RECRUITING

A.O. di Padova

Padua, Italy

NOT YET RECRUITING

A.O.U. di Parma - U.O Ematologia e CTMO

Parma, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

NOT YET RECRUITING

Ospedale Santo Spirito Ospedale -Azienda Sanitaria Locale Di Pescara

Roma, Italy

RECRUITING

Clinica Ematologica Azienda Sanitaria Universitaria Friuli Centrale

Udine, Italy

RECRUITING

Maastricht UMC

Maastricht, Netherlands

RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Oslo Myeloma Center

Oslo, 0450, Norway

RECRUITING

MeSH Terms

Conditions

Smoldering Multiple Myeloma

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Silvia Villa

CONTACT

+31 107033123; silvia.villa@emn.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 27, 2023
• Study Start: May 14, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2031
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

FR (7); NL (3); IT (12); NO (1); FI (1); GR (1)