Hospital Ampang
Ampang, 68000, Malaysia
Location status: Recruiting
NCT Number: NCT07589634
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Ampang, 68000, Malaysia
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ramantamig will be administered as subcutaneous (SC) injection.
Other names: JNJ-79635322
Tocilizumab will be administered as intravenous (IV) injection.
Placebo (saline) will be administered as IV injection.
Time frame: 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.
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 by the end of Day 28 from the ramantamig dose, respectively, will be reported.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 3 years and 6 months
Percentage of participants with re-occurrence of CRS for all Grades will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 3 years and 6 months
Time to the first treatment-emergent infection with toxicity grade >=3 will be reported.
Time frame: Up to approximately 3 years and 6 months
Percentage of participants with primary IgRT prophylaxis use will be reported.
Time frame: Up to approximately 3 years and 6 months
Percentage of participants with secondary IgRT prophylaxis use or without IgRT prophylaxis use will be reported.
Time frame: 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.
Time frame: Up to approximately 3 years and 6 months
Percentage of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
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
Acronym: TRI Pro
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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