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

Phase 2RecruitingNCT07589634

Janssen Research & Development, LLC230 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

230

Conditions

Multiple Myeloma

Interventions

RamantamigDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Beverly Hills Cancer Center (BHCC)

Beverly Hills, California, United States

RECRUITING

Hospital Aleman

Buenos Aires, Argentina

RECRUITING

Instituto Alexander Fleming

Buenos Aires, Argentina

RECRUITING

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

RECRUITING

Concord Repatriation General Hospital

Concord, Australia

RECRUITING

Hospital Ampang

Ampang, Malaysia

RECRUITING

Hospital Sultanah Aminah

Johor Bharu, Malaysia

RECRUITING

Hospital Queen Elizabeth

Kota Kinabalu, Malaysia

RECRUITING

Sarawak General Hospital

Kuching, Malaysia

RECRUITING

Outcomes

Primary Outcomes

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 ramantamig dose will be reported.

Time frame: End of Day 28 from ramantamig dose

Secondary Outcomes

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

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.

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 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 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

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.