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- Sperimentazione clinica NCT07589634
A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma (TRI Pro)
11 maggio 2026 aggiornato da: Janssen Research & Development, LLC
79635322MMY2002: Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
The purpose of this study is to find out whether giving a single dose of tocilizumab before treatment with ramantamig can help prevent or reduce the severity of cytokine release syndrome (CRS) within 28 days from ramantamig, compared to participants who receive placebo.
CRS is an acute inflammatory reaction that can occur during treatment and may be associated with flu-like or other systemic symptoms, such as fever and tiredness.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
230
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Study Contact
- Numero di telefono: 844-434-4210
- Email: Participate-In-This-Study1@its.jnj.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion criteria:
- Documented diagnosis of multiple myeloma (MM) as defined by the criteria: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria; b. Measurable disease at screening as assessed by local laboratory as defined in the protocol
- Received at least 1 prior lines of antimyeloma therapy
- Relapsed or refractory disease as defined: a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by the IMWG response criteria greater than (>) 60 days after cessation of treatment.; b. Refractory disease is defined as failure to achieve a response (that is, partial response or better) or confirmed PD by the IMWG response criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
- Have an eastern cooperative oncology group (ECOG) performance status (PS) score of 0 to 2 at screening and immediately before the start of study treatment administration. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to MM or associated therapy
- Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment
Exclusion criteria:
- Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent
- Major surgery, (for example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Suspected or known allergies, hypersensitivity, or intolerance to ramantamig and tocilizumab or their excipients
- Presence of any of the following: a. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); b. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; c. Any active malignancy other than MM that is considered at high risk of recurrence requiring systemic therapy
- Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Arm A: Tocilizumab + Ramantamig
Participants will receive tocilizumab alongwith ramantamig.
Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier).
|
Ramantamig will be administered as subcutaneous (SC) injection.
Altri nomi:
Tocilizumab will be administered as intravenous (IV) injection.
|
|
Comparatore placebo: Arm B: Placebo + Ramantamig
Participants will receive placebo (saline) alongwith ramantamig.
Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier).
|
Ramantamig will be administered as subcutaneous (SC) injection.
Altri nomi:
Placebo (saline) will be administered as IV injection.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Alive and Free of Treatment-Emergent American Society for Transplantation and Cellular Therapy (ASTCT) Grade Greater Than or Equal to (>=) 2 Cytokine Release Syndrome (CRS)
Lasso di tempo: End of Day 28 from ramantamig dose
|
Percentage of participants alive and free of treatment-emergent ASTCT Grade >=2 CRS without the use of intervening treatment for CRS of any grade by the end of Day 28 from ramantamig dose will be reported.
|
End of Day 28 from ramantamig dose
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the End of Day 28 from Ramantamig Dose
Lasso di tempo: End of Day 28 from ramantamig dose
|
Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 by the end of Day 28 from the ramantamig dose, respectively, will be reported.
|
End of Day 28 from ramantamig dose
|
|
Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment
Lasso di tempo: Up to 37 months
|
Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 during ramantamig treatment will be reported.
|
Up to 37 months
|
|
Percentage of Participants with Re-occurrence of CRS with ASTCT Grade >=2 After the Initial Occurrence of Treatment-Emergent Grade >=2 CRS Event
Lasso di tempo: Up to approximately 3 years and 6 months
|
Percentage of participants with re-occurrence of CRS with ASTCT Grade >=2 after the initial occurrence of treatment-emergent Grade >=2 CRS event will be reported.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants with Re-occurrence of CRS for All Grades
Lasso di tempo: Up to approximately 3 years and 6 months
|
Percentage of participants with re-occurrence of CRS for all Grades will be reported.
|
Up to approximately 3 years and 6 months
|
|
Overall Response Rate (ORR)
Lasso di tempo: Up to approximately 3 years and 6 months
|
ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to progressive disease (PD) or subsequent antimyeloma therapy, in accordance with the international myeloma working group (IMWG) criteria.
|
Up to approximately 3 years and 6 months
|
|
Complete Response (CR) or Better
Lasso di tempo: Up to approximately 3 years and 6 months
|
CR or better rate is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to PD or subsequent antimyeloma therapy, in accordance with the IMWG criteria.
|
Up to approximately 3 years and 6 months
|
|
Very Good Partial Response (VGPR) or Better
Lasso di tempo: Up to approximately 3 years and 6 months
|
VGPR or better rate is defined as the percentage of participants achieving VGPR, CR or sCR prior to PD or subsequent antimyeloma therapy, in accordance with the IMWG criteria.
|
Up to approximately 3 years and 6 months
|
|
Duration of Response (DoR)
Lasso di tempo: Up to approximately 3 years and 6 months
|
DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of PD according to the IMWG response criteria or death due to any cause, whichever occurs first.
|
Up to approximately 3 years and 6 months
|
|
Time to Response (TTR)
Lasso di tempo: Up to approximately 3 years and 6 months
|
TTR is defined as the time from the date of randomization to the date of first documentation of a confirmed response (PR or better) for participants who have PR or better as their best response.
|
Up to approximately 3 years and 6 months
|
|
Progression-Free Survival (PFS)
Lasso di tempo: Up to approximately 3 years and 6 months
|
PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first.
Disease progression will be determined according to the IMWG response criteria.
|
Up to approximately 3 years and 6 months
|
|
Time To Next Line of Therapy (TTNT)
Lasso di tempo: Up to approximately 3 years and 6 months
|
TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.
Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event.
|
Up to approximately 3 years and 6 months
|
|
Time to the First Treatment-emergent Infection with Toxicity Grade >=3
Lasso di tempo: Up to approximately 3 years and 6 months
|
Time to the first treatment-emergent infection with toxicity grade >=3 will be reported.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants with Primary Immunoglobulin Replacement Therapy (IgRT) Prophylaxis Use
Lasso di tempo: Up to approximately 3 years and 6 months
|
Percentage of participants with primary IgRT prophylaxis use will be reported.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants with Secondary IgRT Prophylaxis Use or Without IgRT Prophylaxis Use
Lasso di tempo: Up to approximately 3 years and 6 months
|
Percentage of participants with secondary IgRT prophylaxis use or without IgRT prophylaxis use will be reported.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
Lasso di tempo: Up to approximately 3 years and 6 months
|
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent antimyeloma therapy, whichever is earlier, or any follow-up AE (linked to an existing TEAE) with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy, or any AE that is considered treatment-related regardless of the start date of the event, is considered to be treatment-emergent.
TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0.
Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants with Abnormalities in Laboratory Parameters
Lasso di tempo: Up to approximately 3 years and 6 months
|
Percentage of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants with Incidence of Adverse Events of Clinical Interests
Lasso di tempo: Up to approximately 3 years and 6 months
|
Percentage of participants with incidence of adverse events of clinical interests such as cytopenia will be reported.
|
Up to approximately 3 years and 6 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
20 luglio 2026
Completamento primario (Stimato)
31 dicembre 2027
Completamento dello studio (Stimato)
8 novembre 2030
Date di iscrizione allo studio
Primo inviato
11 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
11 maggio 2026
Primo Inserito (Effettivo)
15 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Malattia cardiovascolare
- Neoplasie
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Neoplasie, plasmacellule
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Disturbi emorragici
- Malattie emiche e linfatiche
- Mieloma multiplo
- tocicizumab
Altri numeri di identificazione dello studio
- 79635322MMY2002 (Altro identificatore: Janssen Research & Development, LLC)
- 2025-524793-42 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
Sì
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Ramantamig
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Janssen Research & Development, LLCReclutamentoMieloma multiploStati Uniti, Spagna, Regno Unito, Olanda, Brasile, Porto Rico, Corea del Sud