NCT06282978Active, not recruitingPhase 2
Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes
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)
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 23 Nov 2023
- Start date
- 23 Nov 2023
- Primary completion date
- 30 May 2025
- Lead sponsor
- PETHEMA Foundation
- Diseases
- Multiple myeloma
- NCT number
- NCT06282978
- EudraCT number
- 2023-504273-21
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 23 Nov 2023 to the primary completion date, 30 May 2025
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior anti-BCMA treatment.
- Stem cell transplant within 12 weeks prior to enrolment.
Other illness
- 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.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| H. Clínic i Provincial de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Unknown status |
| Hospital de Cabuenes Coordinator of this site? Confirm its status | Gijón | Spain | Unknown status |
| Hospital Universitario de Jerez de La Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Unknown status |
| CHU de Gran Canaria Doctor Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Complejo Asistencial Universitario de Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hospital Son Llàtzer Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Unknown status |
| Hospital Clinico Universitario Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Clínico Universitario de Santiago CHUS Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| C.H. de Toledo (Virgen de la Salud) Coordinator of this site? Confirm its status | Toledo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.