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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508426-10-00 | Registry Identifier | EUCT number |
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The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Pre-change Teclistamab | Experimental | Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. Following completion of the planned analysis per protocol, approval of Amendment 3, and upon sponsor notification, participants from treatment phase will be transitioned to Drug Access Long-term Extension (DA-LTE) phase and will continue to receive the study treatment until they have either discontinued, withdrawn, or transitioned to one of the criteria specified in the protocol. Based on primary analysis demonstrating comparability between pre- and post-change teclistamab, flexibility has been introduced to allow participants to switch from their current teclistamab treatment, if necessary. |
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| Arm B: Post-change Teclistamab | Experimental | Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. Following completion of the planned analysis per protocol, approval of Amendment 3, and upon sponsor notification, participants from treatment phase will be transitioned to DA-LTE phase to receive the study treatment until they have either discontinued, withdrawn, or transitioned to one of the criteria specified in the protocol. Based on primary analysis demonstrating comparability between pre- and post-change teclistamab, flexibility has been introduced to allow participants to switch from their current teclistamab treatment, if necessary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teclistamab | Drug | Teclistamab will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab | Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose). | Cycle 1 (28 days cycle): Predose to Day 7 postdose |
| Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose | AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose). | Cycle 1 (28 days cycle): Predose to Day 7 postdose |
| Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1 | Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration. | Cycle 3 (28 days cycle): Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Anti-drug Antibodies (ADAs) | Number of participants with ADAs to teclistamab will be reported. | Up to approximately 3 years |
| Percentage of Participants With Complete Response (CR) or Better Response |
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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 |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Colorado Blood Cancer Institute |
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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Percentage of participants with CR or better response will be reported. CR or better response rate is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.
| Up to approximately 3 years |
| Number of Participants with Adverse Events (AEs) by Severity | An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. 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, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event. | Up to approximately 3 years |
| Number of Participants with Serious Adverse Events (SAEs) | SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important. | Up to approximately 3 years |
| Number of Participants with Abnormal Laboratory Results | Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported. | Up to approximately 3 years |
| Percentage of Participants With Overall Response (Partial Response [PR] or Better) | Percentage of participants with overall response (PR or better) will be reported. Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria. | Up to approximately 3 years |
| Percentage of Participants With Very Good Partial Response (VGPR) or Better Response | Percentage of participants with VGPR or better response will be reported. VGPR or better response rate is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria. | Up to approximately 3 years |
| Denver |
| Colorado |
| 80218 |
| United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Augusta University- Georgia Cancer Center | Augusta | Georgia | 30912 | United States |
| St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health | Indianapolis | Indiana | 46237 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Flinders Medical Centre | Bedford Park | 5042 | Australia |
| Box Hill Hospital | Box Hill | 3128 | Australia |
| Royal Prince Alfred Hospital | Camperdown | 2050 | Australia |
| Epworth Healthcare | Richmond | 3121 | Australia |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Princess Margaret Cancer Centre University Health Network | Toronto | Ontario | M5G 1X6 | Canada |
| CHRU de Lille Hopital Claude Huriez | Lille | 59037 | France |
| Hospices Civils de Lyon HCL | Lyon | 69002 | France |
| CHU Nantes | Nantes | 44093 | France |
| CHU de Bordeaux - Hospital Haut-Leveque | Pessac | 33604 | France |
| Klinikum Chemnitz gGmbH | Chemnitz | 09113 | Germany |
| Universitaetsklinikum Hamburg Eppendorf | Hamburg | 20251 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitatsklinikum Wurzburg | Würzburg | 97080 | Germany |
| Carmel Medical Center | Haifa | 3436212 | Israel |
| Hadassah University Hospita Ein Kerem | Jerusalem | 9112001 | Israel |
| Sheba Medical Center | Ramat Gan | 5266202 | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Ospedali Riuniti Di Ancona | Ancona | 60126 | Italy |
| ASST Papa Giovanni XXIII Bergamo | Bergamo | 24127 | Italy |
| Azienda Ospedaliera Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | 47014 | Italy |
| Ospedale Santa Chiara AO Universitaria Pisana | Pisa | 56126 | Italy |
| Policlinico Universitario Agostino Gemelli | Rome | 00168 | Italy |
| Wojewodzki Szpital Specjalistyczny | Biała Podlaska | 21 500 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80 214 | Poland |
| Pratia Onkologia Katowice | Katowice | 40 519 | Poland |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach | Kielce | 25 734 | Poland |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli | Lublin | 20 090 | Poland |
| Dolnoslaskie Centrum Onkologii | Wroclaw | 53-439 | Poland |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Mary s Hospital | Seoul | 06591 | South Korea |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| ICO L'Hospitalet - Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp. Quiron Madrid Pozuelo | Pozuelo de Alarcón | 28223 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| The Christie NHS Foundation Trust Christie Hospital | Manchester | M20 4BX | United Kingdom |
| Norfolk & Norwich University Hospital | Norwich | NR4 7UY | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | 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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