Clinical trial NCT06282978: Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes
Official title: An Open Label, Multicenter, Phase II Study of Elranatamab as Single Agent for the Treatment of Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes (GEM-RANTAB)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Myeloma in Relapse
Keywords: Relapsed Refractory Multiple Myeloma
Elranatamab
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Treatment with elranatamab will be initiated using a 2-step-up priming regimen: the initial doses of elranatamab will be 12 mg (Cycle 1 Day 1) and 32 mg (Cycle1 Day 4). Participants should be hospitalized and monitored for toxicity (especially CRS/ICANS) for at least 2 days (\~48 hours) beginning on Cycle 1 Day 1, and for 1 day (\~24 hours) for Cycle1 Day 4. The dose of elranatamab should be increased to 76 mg on Cycle 1 Day 8 as long as the participant meets the redosing criteria or deferred until the criteria are met.

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 and maintained for 12 months will stop therapy. After stopping therapy, and if the patient is in sustained undetectable measurable residual disease for at least 12 months, it would be possible to re-start treatment with elranatamab in case the measurable residual disease will be detectable or relapse from CR will occur. Patients who will not achieve undetectable measurable residual disease sustained for 12 months will receive continuous treatment until progressive disease. In both situations, the occurrence of unacceptable toxicity might result into the treatment discontinuation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: 5 Years
Secondary outcomes:
measure: 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.
timeFrame: 5 Years
measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in laboratory values in blood and biochemistry tests.
timeFrame: 5 Years
measure: 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).
timeFrame: 5 Years
measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in vital sign measurements.
timeFrame: 5 Years
measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by pregnancy test.
timeFrame: 5 Years
measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in 12-lead ECG.
timeFrame: 5 Years
measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in Echocardiogram / MUGA.
timeFrame: 5 Years
measure: To determine Circulating Tumor Cells (CTC) at baseline to evaluate its prognostic value.
timeFrame: 5 Years
measure: To determine serum BCMA levels and its correlation with response.
timeFrame: 5 Years
measure: To do gene expression techniques (RNA sequencing and single cell sequencing studies) coupled with intelligent clinical and molecular data analysis (i.e. machine learning) to identify factors that could predict response to elranatamab.
timeFrame: 5 Years
measure: To determine MRD value with alternative methods
timeFrame: 5 Years
measure: To characterize patients' immune system
timeFrame: 5 Years
measure: To define genomic determinants of response/resistance
timeFrame: 5 Years
measure: To evaluate Overall Response Rate of elranatamab in patients with relapsed/refractory multiple myeloma.
timeFrame: 5 years
measure: To evaluate Duration of Response of elranatamab in patients with relapsed/refractory multiple myeloma.
timeFrame: 5 years
measure: To evaluate Time to first and best response of elranatamab in patients with relapsed/refractory multiple myeloma.
timeFrame: 5 years
measure: To evaluate Progression-free survival (PFS) of elranatamab in patients with relapsed/refractory multiple myeloma.
timeFrame: 5 years
measure: To evaluate Overall survival (OS) of elranatamab in patients with relapsed/refractory multiple myeloma.
timeFrame: 5 years
measure: To evaluate PFS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma.
timeFrame: 5 yerars
measure: To evaluate OS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma.
timeFrame: 5 yerars
measure: To evaluate the Incidence of neurologic effects related to elranatamab in patients with relapsed/refractory multiple myeloma.
timeFrame: 5 years
measure: To evaluate the Incidence of cytopenias and infections related to elranatamab in patients with relapsed/refractory multiple myeloma.
timeFrame: 5 years
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago ~ CHUS
state: A Coruña
city: Badalona
country: Spain
facility: Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Catala d'Oncologia (ICO) Hospital Duran i Reynals
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Jerez De La Frontera
country: Spain
facility: Hospital Universitario de Jerez de la Frontera
state: Cádiz
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Illes Balears
city: Las Palmas De Gran Canaria
country: Spain
facility: CHU de Gran Canaria Doctor Negrín
state: Las Palmas
city: Sanchinarro
country: Spain
facility: Hospital HM Sanchinarro
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: Pamplona
country: Spain
facility: Clinica Universidad Navarra (CUN)
state: Navarra
city: Barcelona
country: Spain
facility: H. Clínic i Provincial de Barcelona
city: Gijón
country: Spain
facility: Hospital de Cabueñes
city: Madrid
country: Spain
facility: Instituto de Investigación Sanitaria Hospital 12 de Octubre
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario Salamanca
city: Toledo
country: Spain
facility: C.H. de Toledo (Virgen de la Salud)
Study officials:
affiliation: University of Salamanca
name: María-Victoria Mateos, MD
role: STUDY_CHAIR
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