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NCT Number: NCT07589634

A 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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramantamig

Drug

Ramantamig will be administered as subcutaneous (SC) injection.

Other names: JNJ-79635322

Tocilizumab

Drug

Tocilizumab will be administered as intravenous (IV) injection.

Placebo

Drug

Placebo (saline) will be administered as IV injection.

Primary outcomes

  1. 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)

    Time frame: 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.

Secondary outcomes

  1. 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

    Time frame: 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.

  2. Percentage of Participants with Treatment-Emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 During Ramantamig Treatment

    Time frame: 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.

  3. Percentage of Participants with Re-occurrence of CRS with ASTCT Grade >=2 After the Initial Occurrence of Treatment-Emergent Grade >=2 CRS Event

    Time frame: 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.

  4. Percentage of Participants with Re-occurrence of CRS for All Grades

    Time frame: Up to approximately 3 years and 6 months

    Percentage of participants with re-occurrence of CRS for all Grades will be reported.

  5. Overall Response Rate (ORR)

    Time frame: 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.

  6. Complete Response (CR) or Better

    Time frame: 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.

  7. Very Good Partial Response (VGPR) or Better

    Time frame: 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.

  8. Duration of Response (DoR)

    Time frame: 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.

  9. Time to Response (TTR)

    Time frame: 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.

  10. Progression-Free Survival (PFS)

    Time frame: 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.

  11. Time To Next Line of Therapy (TTNT)

    Time frame: 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.

  12. Time to the First Treatment-emergent Infection with Toxicity Grade >=3

    Time frame: Up to approximately 3 years and 6 months

    Time to the first treatment-emergent infection with toxicity grade >=3 will be reported.

  13. Percentage of Participants with Primary Immunoglobulin Replacement Therapy (IgRT) Prophylaxis Use

    Time frame: Up to approximately 3 years and 6 months

    Percentage of participants with primary IgRT prophylaxis use will be reported.

  14. Percentage of Participants with Secondary IgRT Prophylaxis Use or Without IgRT Prophylaxis Use

    Time frame: Up to approximately 3 years and 6 months

    Percentage of participants with secondary IgRT prophylaxis use or without IgRT prophylaxis use will be reported.

  15. Percentage of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity

    Time frame: 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.

  16. Percentage of Participants with Abnormalities in Laboratory Parameters

    Time frame: Up to approximately 3 years and 6 months

    Percentage of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.

  17. Percentage of Participants with Incidence of Adverse Events of Clinical Interests

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: TRI Pro

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
May 15, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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