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| ID | Type | Description | Link |
|---|---|---|---|
| 64407564MMY1004 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-004502-55 | EudraCT Number | ||
| 2023-503620-60-00 | Registry Identifier | EUCT number |
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The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Regimen A: Talquetamab + Carfilzomib | Experimental | Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. |
|
| Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib | Experimental | Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. |
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| Treatment Regimen C: Talquetamab + Lenalidomide | Experimental | Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally. |
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| Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide | Experimental | Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. |
|
| Treatment Regimen E: Talquetamab + Pomalidomide | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talquetamab | Drug | Talquetamab will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 1 year and 10 months |
| Number of Participants with AEs by Severity | Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE. | Up to 1 year and 10 months |
| Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters | Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported. | Up to 1 year and 6 months |
| Number of Participants with Dose Limiting Toxicity (DLT) | Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity. | Up to 49 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Response to treatment will be evaluated by the investigator based on IMWG criteria. | Up to 1 year and 10 months |
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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 Alabama Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California San Francisco |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/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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Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. |
|
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| Carfilzomib | Drug | Carfilzomib will be administered as an IV infusion. |
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| Daratumumab SC | Drug | Daratumumab will be administered subcutaneously. |
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| Lenalidomide | Drug | Lenalidomide will be self-administered orally. |
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| Pomalidomide | Drug | Pomalidomide will be self-administered orally. |
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| Very Good Partial Response (VGPR) or Better Response Rate |
VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR] + complete response [CR] +VGPR) according to the IMWG 2016 criteria. |
| Up to 1 year and 10 months |
| Complete Response (CR) or Better Response Rate | CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. | Up to 1 year and 10 months |
| Stringent Complete Response (sCR) | sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria. | Up to 1 year and 10 months |
| Duration of Response | Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG 2016 criteria, or death due to disease progression, whichever occurs first. | Up to 1 year and 10 months |
| Time to Response | Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better. | Up to 1 year and 10 months |
| Serum Concentration of Talquetamab | Serum samples will be analyzed to determine concentrations of talquetamab. | Up to 1 year and 10 months |
| Serum Concentration of Daratumumab | Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D. | Up to 1 year and 10 months |
| Number of Participants with Anti-Drug Antibodies to Talquetamab | Number of participants with anti-drug antibodies to talquetamab will be reported. | Up to 1 year and 10 months |
| Number of Participants with Anti-Drug Antibodies to Daratumumab | Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D. | Up to 1 year and 10 months |
| Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) | Number of participants with anti-drug antibodies to rHuPH20 will be reported. | Up to 1 year and 10 months |
| San Francisco |
| California |
| 94143 |
| United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Mt. Sinai School of Medicine | New York | New York | 10029 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| St Vincents Hospital Melbourne | Fitzroy | 3065 | Australia |
| Alfred Health | Melbourne | 3004 | Australia |
| Gold Coast University Hospital | Southport | 4215 | Australia |
| Wollongong Hospital | Wollongong | 2500 | Australia |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZA | Edegem | 2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU Nantes | Nantes | 44093 | France |
| CHU de Bordeaux - Hospital Haut-Leveque | Pessac | 33604 | France |
| Chu Rennes Hopital Pontchaillou | Rennes | 35000 | France |
| Institut Universitaire du cancer de Toulouse-Oncopole | Toulouse | 31059 | France |
| UMCG | Groningen | 9713 GZ | Netherlands |
| Maastricht University Medical Centre | Maastricht | 6229 HX | Netherlands |
| UMCU | Utrecht | 3584 CX | Netherlands |
| University College Hospital London | London | W1T 7HA | United Kingdom |
| The Christie Nhs Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LE | United Kingdom |
| The Royal Marsden NHS Trust Sutton | Surrey | SM2 5PT | United Kingdom |
| 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 |
| C524865 | carfilzomib |
| D000077269 | Lenalidomide |
| C467566 | pomalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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