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)
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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Study Contact
- Telefonnummer: 844-434-4210
- E-Mail: Participate-In-This-Study1@its.jnj.com
Studienorte
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Buenos Aires, Argentinien, C1426ANZ
- Rekrutierung
- Instituto Alexander Fleming
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Buenos Aires, Argentinien, C1118
- Rekrutierung
- Hospital Aleman
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Córdoba, Argentinien, X5016KEH
- Rekrutierung
- Hospital Privado Centro Medico de Cordoba
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Concord, Australien, 2139
- Rekrutierung
- Concord Repatriation General Hospital
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Ampang, Malaysia, 68000
- Rekrutierung
- Hospital Ampang
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Johor Bharu, Malaysia, 80100
- Rekrutierung
- Hospital Sultanah Aminah
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Kota Kinabalu, Malaysia, 88586
- Rekrutierung
- Hospital Queen Elizabeth
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Kuching, Malaysia, 93586
- Rekrutierung
- Sarawak General Hospital
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California
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Beverly Hills, California, Vereinigte Staaten, 90211
- Rekrutierung
- Beverly Hills Cancer Center (BHCC)
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
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Experimental: 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).
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Ramantamig will be administered as subcutaneous (SC) injection.
Andere Namen:
Tocilizumab will be administered as intravenous (IV) injection.
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Placebo-Komparator: 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).
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Ramantamig will be administered as subcutaneous (SC) injection.
Andere Namen:
Placebo (saline) will be administered as IV injection.
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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)
Zeitfenster: End of Day 28 from ramantamig dose
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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.
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End of Day 28 from ramantamig dose
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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
Zeitfenster: End of Day 28 from ramantamig dose
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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.
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End of Day 28 from ramantamig dose
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Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment
Zeitfenster: Up to 37 months
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Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 during ramantamig treatment will be reported.
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Up to 37 months
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Percentage of Participants with Re-occurrence of CRS with ASTCT Grade >=2 After the Initial Occurrence of Treatment-Emergent Grade >=2 CRS Event
Zeitfenster: Up to approximately 3 years and 6 months
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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.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Re-occurrence of CRS for All Grades
Zeitfenster: Up to approximately 3 years and 6 months
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Percentage of participants with re-occurrence of CRS for all Grades will be reported.
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Up to approximately 3 years and 6 months
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Overall Response Rate (ORR)
Zeitfenster: Up to approximately 3 years and 6 months
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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.
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Up to approximately 3 years and 6 months
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Complete Response (CR) or Better
Zeitfenster: Up to approximately 3 years and 6 months
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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.
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Up to approximately 3 years and 6 months
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Very Good Partial Response (VGPR) or Better
Zeitfenster: Up to approximately 3 years and 6 months
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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.
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Up to approximately 3 years and 6 months
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Duration of Response (DoR)
Zeitfenster: Up to approximately 3 years and 6 months
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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.
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Up to approximately 3 years and 6 months
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Time to Response (TTR)
Zeitfenster: Up to approximately 3 years and 6 months
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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.
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Up to approximately 3 years and 6 months
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Progression-Free Survival (PFS)
Zeitfenster: Up to approximately 3 years and 6 months
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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.
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Up to approximately 3 years and 6 months
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Time To Next Line of Therapy (TTNT)
Zeitfenster: Up to approximately 3 years and 6 months
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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.
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Up to approximately 3 years and 6 months
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Time to the First Treatment-emergent Infection with Toxicity Grade >=3
Zeitfenster: Up to approximately 3 years and 6 months
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Time to the first treatment-emergent infection with toxicity grade >=3 will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Primary Immunoglobulin Replacement Therapy (IgRT) Prophylaxis Use
Zeitfenster: Up to approximately 3 years and 6 months
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Percentage of participants with primary IgRT prophylaxis use will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Secondary IgRT Prophylaxis Use or Without IgRT Prophylaxis Use
Zeitfenster: Up to approximately 3 years and 6 months
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Percentage of participants with secondary IgRT prophylaxis use or without IgRT prophylaxis use will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
Zeitfenster: Up to approximately 3 years and 6 months
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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.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Abnormalities in Laboratory Parameters
Zeitfenster: Up to approximately 3 years and 6 months
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Percentage of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.
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Up to approximately 3 years and 6 months
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Percentage of Participants with Incidence of Adverse Events of Clinical Interests
Zeitfenster: Up to approximately 3 years and 6 months
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Percentage of participants with incidence of adverse events of clinical interests such as cytopenia will be reported.
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Up to approximately 3 years and 6 months
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Studienleiter: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Neubildungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Hämatologische Erkrankungen
- Lymphoproliferative Erkrankungen
- Immunproliferative Erkrankungen
- Neubildungen, Plasmazelle
- Hämostasestörungen
- Paraproteinämien
- Bluteiweißstörungen
- Hämorrhagische Störungen
- Hämische und lymphatische Krankheiten
- Multiples Myelom
- Tocilizumab
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 79635322MMY2002 (Andere Kennung: Janssen Research & Development, LLC)
- 2025 (US NIH Stipendium/Vertrag: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524793-42 (EudraCT-Nummer)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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