New study aims to tame dangerous immune reaction in myeloma therapy
NCT ID NCT07589634
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This study tests whether giving a single dose of tocilizumab before the cancer drug ramantamig can prevent or reduce cytokine release syndrome (CRS), a serious flu-like reaction. About 230 adults with relapsed or refractory multiple myeloma will participate. Half will get tocilizumab and half a placebo, and researchers will track CRS severity for 28 days.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 230 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beverly Hills Cancer Center (BHCC)
RECRUITINGBeverly Hills, California, 90211, United States
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Concord Repatriation General Hospital
RECRUITINGConcord, 2139, Australia
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Hospital Aleman
RECRUITINGBuenos Aires, C1118, Argentina
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Hospital Ampang
RECRUITINGAmpang, 68000, Malaysia
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Hospital Privado Centro Medico de Cordoba
RECRUITINGCórdoba, X5016KEH, Argentina
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Hospital Queen Elizabeth
RECRUITINGKota Kinabalu, 88586, Malaysia
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Hospital Sultanah Aminah
RECRUITINGJohor Bharu, 80100, Malaysia
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Instituto Alexander Fleming
RECRUITINGBuenos Aires, C1426ANZ, Argentina
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Sarawak General Hospital
RECRUITINGKuching, 93586, Malaysia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A "Physician & patient-powered" cohort registry
- A phase i study to evaluate the safety and immunogenicity of 3D189 in patients with hematologic malignancies
- Daratumumab, pomalidomide and dexamethasone for Del(17p) positive relapsed and Relapsed/Refractory multiple myeloma patients [DEDALO]
- Can a Four-Drug cocktail tackle Hard-to-Treat myeloma spread?
- Can a protein boost immune recovery after myeloma transplant?
- Can compassion meditation ease the emotional toll of stem cell transplants?