Elranatamab treatment for patients with relapsed or refractory multiple myeloma

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)

This study is testing if a new treatment called elranatamab can help people with relapsed or refractory multiple myeloma feel better and achieve no detectable cancer after their previous treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: PETHEMA Foundation (Academic / other)
• Drugs / interventions: daratumumab, isatuximab, elranatamab
• Locations: 15 sites (Santiago de Compostela, A Coruña and 14 other locations)
• Trial ID: NCT06282978 on ClinicalTrials.gov

What this trial studies

This phase II, open-label, single-arm study evaluates the efficacy and safety of elranatamab monotherapy in patients with relapsed or refractory multiple myeloma who have previously been treated with multiple drug classes. Participants will receive a priming regimen followed by a dose escalation to 76 mg subcutaneously, with treatment monitored for adverse events and cytokine release syndrome. The primary efficacy endpoint is the rate of undetectable measurable residual disease at 6 and 12 months, assessed according to International Myeloma Working Group criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed multiple myeloma who have received at least one or two prior lines of therapy and are refractory to their last treatment.

Not a fit: Patients who have not been previously treated with the required drug classes or who are not refractory to their last line of therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies have shown promising results with similar therapies in treating relapsed or refractory multiple myeloma, indicating potential for success.

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.

Where this trial is running

Santiago de Compostela, A Coruña and 14 other locations

• Hospital Clínico Universitario de Santiago ~ CHUS — Santiago de Compostela, A Coruña, Spain (Not_yet_recruiting)
• Hospital Son Llàtzer — Palma de Mallorca, Balearic Islands, Spain (Not_yet_recruiting)
• Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol — Badalona, Barcelona, Spain (Not_yet_recruiting)
• Institut Catala d'Oncologia (ICO) Hospital Duran i Reynals — L'Hospitalet de Llobregat, Barcelona, Spain (Not_yet_recruiting)
• Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (Not_yet_recruiting)
• Hospital Universitario de Jerez de la Frontera — Jerez de la Frontera, Cádiz, Spain (Not_yet_recruiting)
• CHU de Gran Canaria Doctor Negrín — Las Palmas de Gran Canaria, Las Palmas, Spain (Not_yet_recruiting)
• Hospital HM Sanchinarro — PAU de Sanchinarro, Madrid, Spain (Not_yet_recruiting)
• Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain (Not_yet_recruiting)
• Clinica Universidad Navarra (CUN) — Pamplona, Navarre, Spain (Not_yet_recruiting)
• H. Clínic i Provincial de Barcelona — Barcelona, Spain (Not_yet_recruiting)
• Hospital de Cabueñes — Gijón, Spain (Recruiting)
• Instituto de Investigación Sanitaria Hospital 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
• Hospital Clínico Universitario Salamanca — Salamanca, Spain (Recruiting)
• C.H. de Toledo (Virgen de la Salud) — Toledo, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: María-Victoria Mateos, MD

Conditions Multiple Myeloma in Relapse; Relapsed Refractory Multiple Myeloma; Elranatamab