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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)

27 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

230

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië, C1426ANZ
        • Werving
        • Instituto Alexander Fleming
      • Buenos Aires, Argentinië, C1118
        • Werving
        • Hospital Aleman
      • Córdoba, Argentinië, X5016KEH
        • Werving
        • Hospital Privado Centro Medico de Cordoba
  • Australië
      • Concord, Australië, 2139
        • Werving
        • Concord Repatriation General Hospital
  • Maleisië
      • Ampang, Maleisië, 68000
        • Werving
        • Hospital Ampang
      • Johor Bharu, Maleisië, 80100
        • Werving
        • Hospital Sultanah Aminah
      • Kota Kinabalu, Maleisië, 88586
        • Werving
        • Hospital Queen Elizabeth
      • Kuching, Maleisië, 93586
        • Werving
        • Sarawak General Hospital
  • Verenigde Staten
    • California
      • Beverly Hills, California, Verenigde Staten, 90211
        • Werving
        • Beverly Hills Cancer Center (BHCC)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Geneesmiddel: Ramantamig
Ramantamig will be administered as subcutaneous (SC) injection.
Andere namen:
  • JNJ-79635322
Geneesmiddel: Tocilizumab
Tocilizumab will be administered as intravenous (IV) injection.
Placebo-vergelijker: 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).
Geneesmiddel: Ramantamig
Ramantamig will be administered as subcutaneous (SC) injection.
Andere namen:
  • JNJ-79635322
Geneesmiddel: Placebo
Placebo (saline) will be administered as IV injection.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 juni 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

8 november 2030

Studieregistratiedata

Eerst ingediend

11 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 mei 2026

Eerst geplaatst (Werkelijk)

15 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 79635322MMY2002 (Andere identificatie: Janssen Research & Development, LLC)
  • 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524793-42 (EudraCT-nummer)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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