- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07589634
A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma (TRI Pro)
11 maja 2026 zaktualizowane przez: Janssen Research & Development, LLC
79635322MMY2002: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
230
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Study Contact
- Numer telefonu: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Arm A: Tocilizumab + Ramantamig
Participants will receive tocilizumab alongwith ramantamig.
Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier).
|
Ramantamig will be administered as subcutaneous (SC) injection.
Inne nazwy:
Tocilizumab will be administered as intravenous (IV) injection.
|
|
Komparator placebo: Arm B: Placebo + Ramantamig
Participants will receive placebo (saline) alongwith ramantamig.
Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier).
|
Ramantamig will be administered as subcutaneous (SC) injection.
Inne nazwy:
Placebo (saline) will be administered as IV injection.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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)
Ramy czasowe: End of Day 28 from ramantamig dose
|
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.
|
End of Day 28 from ramantamig dose
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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
Ramy czasowe: 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.
|
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
Ramy czasowe: Up to 37 months
|
Percentage of participants with treatment-emergent CRS of any ASTCT Grade, Grade >=2, and Grade >=3 during ramantamig treatment will be reported.
|
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
Ramy czasowe: Up to approximately 3 years and 6 months
|
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.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants with Re-occurrence of CRS for All Grades
Ramy czasowe: Up to approximately 3 years and 6 months
|
Percentage of participants with re-occurrence of CRS for all Grades will be reported.
|
Up to approximately 3 years and 6 months
|
|
Overall Response Rate (ORR)
Ramy czasowe: Up to approximately 3 years and 6 months
|
ORR 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.
|
Up to approximately 3 years and 6 months
|
|
Complete Response (CR) or Better
Ramy czasowe: Up to approximately 3 years and 6 months
|
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.
|
Up to approximately 3 years and 6 months
|
|
Very Good Partial Response (VGPR) or Better
Ramy czasowe: Up to approximately 3 years and 6 months
|
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.
|
Up to approximately 3 years and 6 months
|
|
Duration of Response (DoR)
Ramy czasowe: Up to approximately 3 years and 6 months
|
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.
|
Up to approximately 3 years and 6 months
|
|
Time to Response (TTR)
Ramy czasowe: Up to approximately 3 years and 6 months
|
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.
|
Up to approximately 3 years and 6 months
|
|
Progression-Free Survival (PFS)
Ramy czasowe: Up to approximately 3 years and 6 months
|
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.
|
Up to approximately 3 years and 6 months
|
|
Time To Next Line of Therapy (TTNT)
Ramy czasowe: Up to approximately 3 years and 6 months
|
TTNT 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.
|
Up to approximately 3 years and 6 months
|
|
Time to the First Treatment-emergent Infection with Toxicity Grade >=3
Ramy czasowe: Up to approximately 3 years and 6 months
|
Time to the first treatment-emergent infection with toxicity grade >=3 will be reported.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants with Primary Immunoglobulin Replacement Therapy (IgRT) Prophylaxis Use
Ramy czasowe: Up to approximately 3 years and 6 months
|
Percentage of participants with primary IgRT prophylaxis use will be reported.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants with Secondary IgRT Prophylaxis Use or Without IgRT Prophylaxis Use
Ramy czasowe: Up to approximately 3 years and 6 months
|
Percentage of participants with secondary IgRT prophylaxis use or without IgRT prophylaxis use will be reported.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
Ramy czasowe: Up to approximately 3 years and 6 months
|
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.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants with Abnormalities in Laboratory Parameters
Ramy czasowe: Up to approximately 3 years and 6 months
|
Percentage of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.
|
Up to approximately 3 years and 6 months
|
|
Percentage of Participants with Incidence of Adverse Events of Clinical Interests
Ramy czasowe: Up to approximately 3 years and 6 months
|
Percentage of participants with incidence of adverse events of clinical interests such as cytopenia will be reported.
|
Up to approximately 3 years and 6 months
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
20 lipca 2026
Zakończenie podstawowe (Szacowany)
31 grudnia 2027
Ukończenie studiów (Szacowany)
8 listopada 2030
Daty rejestracji na studia
Pierwszy przesłany
11 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
11 maja 2026
Pierwszy wysłany (Rzeczywisty)
15 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
15 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby naczyniowe
- Choroby układu krążenia
- Nowotwory
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Choroby hematologiczne
- Zaburzenia limfoproliferacyjne
- Zaburzenia immunoproliferacyjne
- Nowotwory, komórki plazmatyczne
- Zaburzenia hemostatyczne
- Paraproteinemie
- Zaburzenia białek krwi
- Zaburzenia krwotoczne
- Choroby hemowe i limfatyczne
- Szpiczak mnogi
- Tocilizumab
Inne numery identyfikacyjne badania
- 79635322MMY2002 (Inny identyfikator: Janssen Research & Development, LLC)
- 2025-524793-42 (Numer EudraCT)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Tak
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Szpiczak mnogi
-
Assiut UniversityJeszcze nie rekrutacja
Badania kliniczne na Ramantamig
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Janssen Research & Development, LLCRekrutacyjnySzpiczak mnogiStany Zjednoczone, Hiszpania, Zjednoczone Królestwo, Holandia, Brazylia, Portoryko, Korea Południowa