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Multiple MyelomaPhase 2TRI ProNCT07589634

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

A Phase 2 study testing Ramantamig and Tocilizumab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 60 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Ramantamig and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
230 participants
Where
60 sitesin 10 countries
Study dates
30 Jun 2026to 30 Jul 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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
  • 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

Trial locations and contacts

60 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

60 sites in 10 countries

United States9 sites, 9 recruiting

  • Beverly Hills Cancer Center (BHCC)

    Beverly Hills, California, 90211

    Recruiting

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Recruiting

  • City of Hope Phoenix

    Goodyear, Arizona, 85338

    Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Recruiting

  • Stanford University Medical Center

    Palo Alto, California, 94304

    Recruiting

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Recruiting

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Greece7 sites, 7 recruiting

  • Uni General Hospital of Alexandroupolis

    Alexandroupoli, 681 00

    Recruiting

  • 251 Air Force General Hospital

    Athens, 115 25

    Recruiting

  • Alexandra General Hospital of Athens

    Athens, 11528

    Recruiting

  • Metaxa Cancer Center Hospital Of Piraeus

    Piraeus, 18537

    Recruiting

  • General University Hospital of Patras

    Rio, 265 04

    Recruiting

  • Theageneio Cancer Hospital

    Thessaloniki, 546 39

    Recruiting

  • Hippokration Hospital

    Thessaloniki, 54642

    Recruiting

Other trials in Greece

Spain7 sites, 7 recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041

    Recruiting

  • Hosp. de Leon

    León, 24071

    Recruiting

  • Hosp. Univ. La Paz

    Madrid, 28046

    Recruiting

  • Hosp. Blua Sanitas Valdebebas

    Madrid, 28055

    Recruiting

  • Hosp Regional Univ de Malaga

    Málaga, 29010

    Recruiting

  • Hosp. de Navarra

    Pamplona, 31008

    Recruiting

  • Hosp. Univ. Dr. Peset

    Valencia, 46017

    Recruiting

Other trials in Spain

France6 sites, 6 recruiting

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

    Recruiting

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100

    Recruiting

  • CHU de Grenoble

    La Tronche, 38700

    Recruiting

  • Centre de Cancerologie de la Sarthe

    Le Mans, 72100

    Recruiting

  • CHU Nantes - Hotel Dieu

    Nantes, 44000

    Recruiting

  • Centre Hospitalier de Quimper Cornouaille

    Quimper, 29000

    Recruiting

Other trials in France

Portugal6 sites, 6 recruiting

  • Uls Braga - Hosp. Braga

    Braga, 4710 243

    Recruiting

  • Ipo Lisboa

    Lisbon, 1099 023

    Recruiting

  • Hosp. Cuf Descobertas

    Lisbon, 1998 018

    Recruiting

  • Uls Santo Antonio - Hosp. Santo Antonio

    Porto, 4050 342

    Recruiting

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319

    Recruiting

  • Uls Gaia Espinho

    Vila Nova de Gaia, 4434 502

    Recruiting

Other trials in Portugal

Argentina5 sites, 5 recruiting

  • Hospital Aleman

    Buenos Aires, C1118

    Recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

    Recruiting

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ

    Recruiting

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

    Recruiting

  • Hospital Universitario Austral

    Pilar, 1629

    Recruiting

Other trials in Argentina

Australia5 sites, 5 recruiting

  • Flinders Medical Centre

    Bedford Park, 5042

    Recruiting

  • Sunshine Coast University Hospital

    Birtinya, 4575

    Recruiting

  • Concord Repatriation General Hospital

    Concord, 2139

    Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

    Recruiting

  • Wollongong Hospital

    Wollongong, 2500

    Recruiting

Other trials in Australia

Hungary5 sites, 5 recruiting

  • Semmelweis Egyetem

    Budapest, 1088

    Recruiting

  • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

    Budapest, 1097

    Recruiting

  • Orszagos Onkologiai Intezet

    Budapest, 1122

    Recruiting

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624

    Recruiting

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

    Szeged, 6725

    Recruiting

Other trials in Hungary

Malaysia5 sites, 5 recruiting

  • Hospital Ampang

    Ampang, 68000

    Recruiting

  • Hospital Pulau Pinang

    George Town, 10450

    Recruiting

  • Hospital Sultanah Aminah

    Johor Bharu, 80100

    Recruiting

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88586

    Recruiting

  • Sarawak General Hospital

    Kuching, 93586

    Recruiting

Other trials in Malaysia

Sweden5 sites, 5 recruiting

  • Falu Lasarett Medicinkliniken Falun

    Falun, 791 82

    Recruiting

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

    Recruiting

  • Skanes universitetssjukhus

    Lund, 221 85

    Recruiting

  • Karolinska University Hospital Huddinge

    Stockholm, 141 86

    Recruiting

  • Akademiska Sjukhuset

    Uppsala, 752 37

    Recruiting

Other trials in Sweden

About this study

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

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.

Being tested
Ramantamig, Tocilizumab, Placebo
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamantamigDrug

    Also called JNJ-79635322

    Ramantamig will be administered as subcutaneous (SC) injection.

  • TocilizumabDrug

    Tocilizumab will be administered as intravenous (IV) injection.

  • PlaceboDrug

    Placebo (saline) will be administered as IV injection.

Study groups in NCT07589634
Study groupRoleWhat they receive
Arm A: Tocilizumab + RamantamigExperimentalParticipants 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).
Receives: Drug: Ramantamig; Drug: Tocilizumab
Arm B: Placebo + RamantamigPlacebo comparatorParticipants 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).
Receives: Drug: Ramantamig; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: By the end of Day 28 from first ramantamig dose

Secondary outcomes (14)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 38 months

  5. Overall Response

    Overall response 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.

    Measured: Up to 38 months

  6. Complete Response (CR) or Better

    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.

    Measured: Up to 38 months

  7. Very Good Partial Response (VGPR) or Better

    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.

    Measured: Up to Month 38

  8. Duration of Response (DoR)

    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.

    Measured: Up to 38 months

  9. Time to Response (TTR)

    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.

    Measured: Up to 38 months

  10. Progression-Free Survival (PFS)

    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.

    Measured: Up to Month 38

  11. Time to Subsequent Antimyeloma Therapy

    Time to subsequent antimyeloma therapy 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.

    Measured: Up to Month 38

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

    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.

    Measured: Up to 38 months

  13. Percentage of Participants with Abnormalities in Laboratory Parameters

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

    Measured: Up to 38 months

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

    Percentage of participants with incidence of adverse events of clinical interests such as cytopenia will be reported.

    Measured: Up to 38 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start30 Jun 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07589634
Sponsor's protocol ID
79635322MMY2002
Other IDs
2025-524793-42, 2025
Acronym
TRI Pro
Status last verified
Nov 2026
First submitted
11 May 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramantamig and Tocilizumab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 60 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Greece, Spain, France, Portugal and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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: By the end of Day 28 from first ramantamig dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07589634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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