Informations générales (source: ClinicalTrials.gov)
A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY
Interventional
Phase 3
Pfizer (Voir sur ClinicalTrials)
février 2024
décembre 2027
16 avril 2025
The purpose of this study is to learn about the study medicine called elranatamab.This
study aims to compare elranatamab to other medicines for the treatment of MM (a type of
cancer).
This study is seeking participants who:
- Are 18 years of age or older and have MM.
- Have received treatments before for MM.
- Have MM that has returned or not responded to their most recent treatment.
Half of the participants will receive elranatamab. The other half of participants will
receive a combination therapy selected by the study doctor. The selected combination
therapy will include 2 to 3 different medicines commonly used to treat MM.
Elranatamab will be given as a shot under the skin at the study clinic about once a week.
This may change to a smaller number of shots later in the study.
The medicines in the combination therapy will be taken by mouth (at home or at the study
clinic) AND will be given either as:
- a shot under the skin at the study clinic
- through a needle in the vein at the study clinic The number of times these medicines
will be taken depends on what combination therapy the study doctor selects.
Participants may continue to receive elranatamab or a combination therapy until their MM
is no longer responding. The study team will see how each participant is doing with the
study treatment during regular visits at the study clinic. The study team will continue
to follow-up with participants after study treatment with telephone contacts (or visits).
The study will compare the experiences of people receiving elranatamab to those people
receiving a combination therapy. This will help learn about the safety and how effective
elranatamab is.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | BENRAMDANE Riad | 14/02/2025 09:03:14 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier de Cornouaille - 29107 - Quimper - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Dunkerque - 59385 - Dunkirk - Nord-pas-de-calais - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la Côte Basque - 64109 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier du Mans - 72037 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois - 54511 - Vandoeuvre lès Nancy - Lorraine - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau - 37032 - Tours - France | Contact (sur clinicalTrials) | ||||
| CHD Vendee - 85000 - La Roche-sur-Yon - Vendée - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux Haut-Leveque - 33600 - Pessac - Aquitaine - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Prior diagnosis of multiple myeloma as defined by International Myeloma Working
Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy
including prior anti-cluster of differentiation 38 (CD38) antibody and prior
lenalidomide.
- Documented evidence of progressive disease or failure to achieve a response to last
line of therapy per IMWG criteria.
- Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5
g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved
immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC
ratio (<0.26 or >1.65).
- Have clinical laboratory values within the specified range.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
- Not pregnant or breastfeeding and willing to use contraception.
- Prior diagnosis of multiple myeloma as defined by International Myeloma Working
Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy
including prior anti-cluster of differentiation 38 (CD38) antibody and prior
lenalidomide.
- Documented evidence of progressive disease or failure to achieve a response to last
line of therapy per IMWG criteria.
- Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5
g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved
immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC
ratio (<0.26 or >1.65).
- Have clinical laboratory values within the specified range.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
- Not pregnant or breastfeeding and willing to use contraception.
- Smoldering multiple myeloma.
- Plasma cell leukemia.
- Amyloidosis.
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin
abnormalities (POEMS) syndrome.
- Known central nervous system (CNS) involvement or clinical signs of myelomatous
meningeal involvement.
- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host
disease.
- Any active, uncontrolled bacterial, fungal, or viral infection.
- Any other active malignancy within 3 years prior to enrolment (exceptions include,
adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
- Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or
CD3-redirecting therapy.
- Unable to receive investigator's choice therapy.
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- Administration with an investigational product (e.g. drug or vaccine) within 30 days
preceding the first dose of study intervention used in this study.