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Taking people in MalaysiaPhase 2

Tests tocilizumab to prevent a reaction during ramantamig treatment in myeloma

Tests whether tocilizumab before ramantamig helps prevent cytokine release syndrome in adults with myeloma.

Key facts

Who runs it
Janssen Research & Development, LLC
Where
Ampang, George Town, Johor Bharu, Kota Kinabalu, and Kuching, MalaysiaSee the 5 sitesAlso in 9 other countries, 55 sites
Registry title
A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
Status
Recruiting
Phase
Phase 2
People taking part
230 people, planned
Started
30 Jun 2026
Expected to end
30 Jul 2030
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Ramantamig
  • Tocilizumab
  • Placebo
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with multiple myeloma that came back or stopped responding after at least 1 earlier treatment. It tests whether tocilizumab before ramantamig helps prevent cytokine release syndrome.

Age
18 Years or older
Sex
All sexes
Disease stage
Multiple myeloma that is relapsed (came back) or refractory (did not respond), with disease that can be measured at screening.
Earlier treatment
At least 1 earlier line of anti-myeloma treatment.

Main reasons for not taking part

  • Any other anticancer treatment or investigational drug at the same time
  • Major surgery within 2 weeks before the first dose, or planned during the study
  • Known allergy or intolerance to ramantamig or tocilizumab
  • Another active cancer, or a past cancer at high risk of coming back that needs systemic therapy
  • Known active or past myeloma in the central nervous system

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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
  • Have clinical laboratory values meeting the criteria specified in the protocol

Who cannot take part

  • 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
  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which of these best describes your myeloma treatment so far?
  • Has a doctor told you that your myeloma can be measured in your blood or urine tests?
  • Has a doctor told you that you have myeloma in the brain or in the fluid and membranes around the brain and spinal cord, now or in the past?

Where in Malaysia

Also in 9 other countries, 55 sites

  • Hospital AmpangAmpang, MalaysiaTaking people
  • Hospital Pulau PinangGeorge Town, MalaysiaTaking people
  • Hospital Sultanah AminahJohor Bharu, MalaysiaTaking people
  • Hospital Queen ElizabethKota Kinabalu, MalaysiaTaking people
  • Sarawak General HospitalKuching, MalaysiaTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm A: Tocilizumab + RamantamigTreatment being tested

    Participants will receive tocilizumab along with ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier).

    Treatment: Ramantamig and Tocilizumab

  • Arm B: Placebo + RamantamigPlacebo, for comparison

    Participants will receive placebo (saline) along with ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier).

    Treatment: Ramantamig and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests tocilizumab to prevent a reaction during ramantamig treatment in myelomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07589634, who can take part
Record updated
3 November 2026