A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ramantamig

    Drug

    Ramantamig will be administered as subcutaneous (SC) injection.

  • Tocilizumab

    Drug

    Tocilizumab will be administered as intravenous (IV) injection.

  • Placebo

    Drug

    Placebo (saline) will be administered as IV injection.

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: Arm A: Tocilizumab + RamantamigExperimental treatment 2 interventions
Group B: Arm B: Placebo + RamantamigPlacebo comparator 2 interventions

Trial outcomes

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)

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 first ramantamig dose will be reported.

Time frame
By the end of Day 28 from first ramantamig dose

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 First 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 first ramantamig dose, respectively, will be reported.

Time frame
By the end of Day 28 from first ramantamig dose
2

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

Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade \>=2, and Grade \>=3 during ramantamig treatment will be reported.

Time frame
Up to 38 months
3

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

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.

Time frame
Up to 38 months
4

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

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

Time frame
Up to 38 months

Other outcomes

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