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

NCT06282978 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GEM-RANTAB2023-504273-21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 15

Brief Summary

The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment. Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators. Safety refers to the measurement of: i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests). ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria. iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and infections The study consists of a screening/baseline period, a treatment period, and a posttreatment follow-up period. The study includes a periodic review of safety data, that will be independently analyzed by the Data Safety Independent Committee (DSMC) and will recommend how to proceed with the study.

Conditions

Multiple Myeloma in Relapse

Keywords

Relapsed Refractory Multiple Myeloma; Elranatamab

Outcome Measures

Primary Outcomes (1)

• To evaluate the rate of Undetectable Measurable Residual Disease (uMRD) at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators of elranatamab in patients with relapsed/refractory multiple myeloma.

  To evaluate the rate of uMRD at 6 and 12 months (defined as the percentage of participants who are MRD negative by next generation flow cytometry (NGF) method and with a sensitivity level of at least 10-5) of elranatamab in patients with relapsed/refractory multiple myeloma. Next generation flow cytometry is a reproducible biomarker to detect the presence of phenotypically abnormal clonal plasma cells (Measurable Residual Disease). The presence of surface markers (CD138, CD27, CD38, CD56, CD45, CD19) and certain morphological characteristics (FSC and SSC) permit the specific identification of plasma cells (PC). This will permit unique, high specificity confirmation of the monoclonality of phenotypically abnormal plasma cells (by light chain restriction). Said cells will have been clearly identified by low antigen expression (CD19, CD27, CD38, CD45, CD81) or overexpression (CD56, CD117, CD138).

  5 Years

Secondary Outcomes (22)

• To evaluate annually by NGF until loss of response, the rate of Undetectable Measurable Residual Disease (% of patients with MRD negative by NGF method and with a sensitivity level of 10-5) of elranatamab in patients with R/R multiple myeloma.

  5 Years

• Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in laboratory values in blood and biochemistry tests.

  5 Years

• Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in physical examination and ECOG performance status scale (0-5).

  5 Years

• Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in vital sign measurements.

  5 Years

• Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by pregnancy test.

  5 Years

Study Arms (1)

Elranatamab

EXPERIMENTAL

Elranatamab will be administered by subcutaneous (SC) injection

Drug: Elranatamab (PF-06863135)

Interventions

Elranatamab (PF-06863135) DRUG

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.

Elranatamab

Eligibility Criteria

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

You may qualify if:

• Male or female, 18 years or older (at the time consent is obtained).
• Patient who, in the investigator's opinion, is able to comply with the protocol requirements.
• Prior diagnosis of MM as defined according to IMWG criteria.
• Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• Relapse multiple myeloma patients that have received at least 1 or 2 prior lines of therapy including at least to one proteasome inhibitor (bortezomib, carfilzomib or ixazomib), one immunomodulatory drug (lenalidomide is mandatory and patients can be also have been exposed to pomalidomide) and at least one anti-CD38 monoclonal antibody (daratumumab or isatuximab).
• Patients must be refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.
• Patient must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200 mg/24 h. For patients in whom disease is only measurable by serum FLC, the involved FLC should be ≥ 10mg/dL (100 mg/L), with an abnormal serum FLC ratio.

You may not qualify if:

• Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), POEMS syndrome (defined by the presence of peripheral neuropathy, organomegaly, endocrinopathy, monoclonal plasma-cells proliferative disorder, and skin changes) or plasma cell leukemia.
• Prior anti-BCMA treatment.
• Subject has peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.
• History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
• Stem cell transplant within 12 weeks prior to enrolment.

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (15)

Hospital Clínico Universitario de Santiago ~ CHUS

Santiago de Compostela, A Coruña, 15706, Spain

NOT YET RECRUITING

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

NOT YET RECRUITING

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

Badalona, Barcelona, 08916, Spain

NOT YET RECRUITING

Institut Catala d'Oncologia (ICO) Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

NOT YET RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

NOT YET RECRUITING

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

NOT YET RECRUITING

CHU de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

NOT YET RECRUITING

Hospital HM Sanchinarro

PAU de Sanchinarro, Madrid, 28050, Spain

NOT YET RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

NOT YET RECRUITING

Clinica Universidad Navarra (CUN)

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

H. Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

NOT YET RECRUITING

Hospital de Cabueñes

Gijón, 33394, Spain

RECRUITING

Instituto de Investigación Sanitaria Hospital 12 de Octubre

Madrid, 28041, Spain

NOT YET RECRUITING

Hospital Clínico Universitario Salamanca

Salamanca, 37007, Spain

RECRUITING

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

Toledo, 45005, Spain

NOT YET RECRUITING

Related Publications (43)

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MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• María-Victoria Mateos, MD

  University of Salamanca

  STUDY CHAIR

Central Study Contacts

María-Victoria Mateos, MD

CONTACT

+34 923 291 100; mvmateos@usal.es

Verónica González de la Calle, MD

CONTACT

+34 923 291 100; vgcalle@saludcastillayleon.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label, multicenter, phase II study of Elranatamab as single agent. The primary aiming is to evaluate the efficacy of elranatamab monotherapy in participants with relapsed refractory multiple myeloma (RRMM) who had received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy as evaluated with the rate of complete Response and Undetectable Measurable Residual Disease. Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: February 28, 2024
• Study Start: November 23, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)