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| ID | Type | Description | Link |
|---|---|---|---|
| 64007957MMY1004 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-004404-33 | EudraCT Number | ||
| 2023-503440-14-00 | Registry Identifier | EUCT number |
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The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide | Experimental | Participants will receive teclistamab plus daratumumab plus pomalidomide. |
|
| Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles) | Experimental | Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles. |
|
| Treatment Regimen C: Teclistamab + Nirogacestat | Experimental | Participants will receive teclistamab plus nirogacestat. |
|
| Treatment Regimen D: Teclistamab + Lenalidomide | Experimental | Participants will receive teclistamab plus lenalidomide. |
|
| Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide | Experimental | Participants will receive teclistamab plus daratumumab plus lenalidomide. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teclistamab | Drug | Participants will receive teclistamab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Incidence of Adverse Events (AEs) | An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. | Up to 2 year and 5 months |
| Number of Participants with AEs by Severity | Number of participants with AEs by severity will be reported. | Up to 2 year and 5 months |
| Number of Participants with Abnormalities in Laboratory Values | Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported. | Up to 2 year and 5 months |
| Number of Participants with Dose-Limiting Toxicity (DLT) | The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher. | Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the proportion of participants who achieve partial response (PR) or better according to the international myeloma working group (IMWG) 2016 criteria. | Up to 2 year and 5 months |
| Very Good Partial Response (VGPR) or Better Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research and Development, LLC Clinical Trial | Janssen Research and Development LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California San Francisco |
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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| Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles) | Experimental | Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles. |
|
|
| Daratumumab | Drug | Participants will receive daratumumab. |
|
| Pomalidomide | Drug | Participants will receive pomalidomide. |
|
| Lenalidomide | Drug | Participants will receive lenalidomide. |
|
| Bortezomib | Drug | Participants will receive bortezomib. |
|
| Nirogacestat | Drug | Participants will receive nirogacestat. |
|
VGPR or better response rate is defined as the proportion 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 2 year and 5 months |
| Complete Response (CR) or Better Response Rate | CR or better response rate is defined as the proportion of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria. | Up to 2 year and 5 months |
| Stringent Complete Response (sCR) Rate | sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria. | Up to 2 year and 5 months |
| Duration of Response | Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria. | Up to 2 year and 5 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 2 year and 5 months |
| Serum Concentrations of Teclistamab | Serum concentrations of teclistamab will be reported. | Up to 2 year and 5 months |
| Serum Concentrations of Daratumumab | Serum concentrations of daratumumab will be reported. | Up to 2 year and 5 months |
| Serum Concentrations of Nirogacestat | Serum concentration of nirogacestat will be reported. | Up to 2 year and 5 months |
| Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab | Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens. | Up to 2 year and 5 months |
| Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab | Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, E and F. | Up to 2 year and 5 months |
| Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) | Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F. | Up to 2 year and 5 months |
| San Francisco |
| California |
| 94143 |
| United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Winship Cancer Institute Emory University | Atlanta | Georgia | 30322 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110-1032 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | 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 |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| St Vincents Hospital Melbourne | Fitzroy | 3065 | Australia |
| Alfred Health | Melbourne | 3004 | Australia |
| Calvary Mater Newcastle Hospital | Waratah | 2298 | Australia |
| UZA | Edegem | 2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Centre Leon Berard | Lyon | 69373 | France |
| 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 |
| University College Hospital | London | NW1 2BU | United Kingdom |
| The Christie Nhs Foundation Trust | Manchester | M20 4BX | 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 |
|---|---|
| C556306 | daratumumab |
| C467566 | pomalidomide |
| D000077269 | Lenalidomide |
| D000069286 | Bortezomib |
| C550722 | nirogacestat |
| 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 |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
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