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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507989-76-00 | Registry Identifier | EUCT number |
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The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) Therapy | Experimental | Participants with relapsed and/or refractory multiple myeloma (RRMM) will be administered Cilta-cel followed by multiple cycles of talquetamab consolidation treatment and will be followed up until death, lost to follow-up, consent withdrawal, or study end, whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilta-cel | Drug | Cilta-cel infusion will be administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 | An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. The severity of AEs has 5 grades based on NCI-CTCAE version 5.0 criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death. | Up to 3 years and 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response (OR) | The percentage of participants who have a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria will be reported. | Up to 3 years and 5 months |
| Percentage of Participants with Very Good Partial Response (VGPR) or Better |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States | ||
| Norton Cancer Institute |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.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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|
| Talquetamab | Drug | Talquetamab will be administered subcutaneously. |
|
|
The percentage of participants who achieve a VGPR or better response according to the IMWG response criteria will be reported. |
| Up to 3 years and 5 months |
| Percentage of Participants with Complete Response (CR) or Stringent Complete Response (sCR) | The percentage of participants with best overall response of CR or sCR will be reported according to IMWG criteria. | Up to 3 years and 5 months |
| Duration of Response (DOR) | DOR is defined as the time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease (PD) (defined in the IMWG response criteria) or death due to any cause, whichever occur first. | Up to 3 years and 5 months |
| Time to Response (TTR) | TTR is defined as the time between date of the first study treatment and the first efficacy evaluation that the participant met all criteria for PR or better. | Upto 3 years and 5 months |
| Progression Free Survival (PFS) | PFS is defined as the time from the date of the first study treatment to the date of first documented disease progression (defined in the IMWG response criteria), or death due to any cause, whichever occurs first. | Up to 3 years and 5 months |
| Overall Survival | Overall Survival is measured from the date of the first study treatment to the date of the participant's death. | Up to 3 years and 5 months |
| Louisville |
| Kentucky |
| 40207 |
| United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Royal Prince Alfred Hospital | Camperdown | 2050 | Australia |
| Austin Hospital | Heidelberg | 3084 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | 3000 | Australia |
| The Alfred Hospital | Melbourne | 3004 | Australia |
| 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 |
|---|---|
| C000730985 | talquetamab |
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