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| ID | Type | Description | Link |
|---|---|---|---|
| 79635322MMY2002 | Other Identifier | Janssen Research & Development, LLC | |
| 2025-524793-42 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Tocilizumab + Ramantamig | Experimental | 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). |
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| Arm B: Placebo + Ramantamig | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramantamig | Drug | Ramantamig will be administered as subcutaneous (SC) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 ramantamig dose will be reported. | End of Day 28 from ramantamig dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ampang | Recruiting | Ampang | 68000 | Malaysia |
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
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| Tocilizumab | Drug | Tocilizumab will be administered as intravenous (IV) injection. |
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| Placebo | Drug | Placebo (saline) will be administered as IV injection. |
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| 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. | 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 | 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 | 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) | 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 | 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 | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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