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| ID | Type | Description | Link |
|---|---|---|---|
| 54767414MMY2093 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-505792-71-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate the rate of response (how effectively treatment is working) with signs of potential cure at 5 years after the start of induction treatment. This is defined as a composite of sustained (at least 2 years) minimal residual disease (MRD) negativity with complete response/stringent complete response (CR/sCR) and a positron emission tomography/computed tomography (PET/CT) scan that does not show any signs of cancer at 5 years. MRD negativity and CR/sCR is defined as no detectable signs of remaining cancer cells after the treatment. This study will also characterize how well the treatments administered work in the study through progression-free survival (PFS). PFS is defined as the length of time during and after the treatment of a disease, that a participant lives with the disease, but it does not get worse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: DVRd Induction + Tal-D Consolidation + Cilta-cel | Experimental | Participants will undergo apheresis followed by 4 cycles of DVRd induction (each cycle is of 28 days) and cilta-cel will be generated from the participants' T-cells selected from the apheresis product. Upon completion of cilta-cel production, product release, and completion of induction, participants will begin consolidation with 4 cycles of Tal-D (each cycle is of 28 days), followed by a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days); cilta-cel will be administered 5 to 7 days after the start of the conditioning regimen. |
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| Cohort B: DVRd Induction + Cilta-cel + Tal-D and Tec-D Consolidation | Experimental | Participants will undergo apheresis followed by 4 cycles of DVRd induction and Cilta-cel will be generated from the participants' T-cells selected from the apheresis product. Upon completion of cilta-cel production, product release and completion of induction, participants will begin consolidation with a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days) with infusion of cilta-cel 5 to 7 days after the start of the conditioning regimen. Following cilta-cel infusion, alternating cycles of Tal-D (Cycle 1, 3, 5, and 7) and Tec-D (Cycle 2, 4, 6, and 8) will be started, no earlier than Day 84 and no later than Day 168 post cilta-cel infusion. Each cycle of Tal-D or Tec-D is 84 days which includes an extended treatment-free interval. |
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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 |
|---|---|---|
| Rate of Response with Curative Potential | Rate of Response with curative potential is defined as the percentage of participants with a composite of durable (at least 2 years) minimal residual disease (MRD) (10^-5) negativity with complete response/stringent complete response (CR/sCR) by serology and negative positron emission tomography/computed tomography (PET/CT) imaging at 5-years after start of induction therapy. This includes: negative imaging at 5-year landmark time; MRD-negative status (at 10^-5) in 2 bone marrow examinations that are a minimum of 2 years apart; response of CR or better per the International Myeloma Working Group (IMWG) criteria; no examination showing MRD-positive status or relapse from CR in between assessments. | Up to 5 years |
| Progression Free Survival (PFS) Rate at 3-Year | PFS is defined as the time from the date of randomization to either progressive disease (PD), according to the IMWG response criteria, or death, whichever occurs first. | At 3-year |
| PFS Rate at 5-Year | PFS is defined as the time from the date of randomization to either PD, according to the IMWG response criteria, or death, whichever occurs first. | At 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR; Partial response [PR] or better) | ORR (PR or better) is defined as the percentage of participants with best overall response of PR or better according to IMWG response criteria. | Up to 5 years |
| CR or Better Rate |
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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 |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | 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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| Talquetamab | Drug | Talquetamab will be administered subcutaneously. |
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| Daratumumab | Drug | Daratumumab will be administered subcutaneously as a part of DVRd induction and Tal-D or Tec-D consolidation. |
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| Teclistamab | Drug | Teclistamab will be administered subcutaneously. |
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| Bortezomib | Drug | Bortezomib will be administered subcutaneously as a part of induction. |
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| Lenalidomide | Drug | Lenalidomide will be administered orally as a part of induction. |
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| Dexamethasone | Drug | Dexamethasone will be administered orally as a part of induction. |
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| Cyclophosphamide | Drug | Cyclophosphamide will be administered intravenously as a part of conditioning regimen. |
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| Fludarabine | Drug | Fludarabine will be administered intravenously as a part of conditioning regimen. |
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Rate of CR or better is defined as the percentage of participants with best overall response of CR or better according to IMWG response criteria.
| Up to 5 years |
| Very Good Partial Response (VGPR) or Better Rate | Rate of VGPR or better is defined as the percentage of participants with best overall response of VGPR or better rate according to IMWG response criteria. | Up to 5 years |
| Duration of Response (DOR) | DOR is calculated among responders (with a PR or better response) from the date of initial documented response (PR or better) to the date of first documented evidence of PD as defined according to IMWG criteria or death due to any cause, whichever occurs first. | Up to 5 years |
| Time to First Response (TTR) | Time to response (that is, time to first response) is defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better based on the computerized algorithm per IMWG criteria for those who had PR or better as their best response. | Up to 5 years |
| Duration of CR or Better Response | Duration of CR or better response is calculated among responders (with a CR or better response) from the date of initial documented response CR or better to the date of first documented evidence of PD as defined according to IMWG criteria or death due to any cause, whichever occurs first. | Up to 5 years |
| Time to First CR or Better Response | Time to first CR or better response is defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for CR or better based on the computerized algorithm per IMWG criteria. | Up to 5 years |
| PFS on next line therapy (PFS2) | PFS2 is defined as time from randomization to progression on the next line of therapy or death, whichever comes first. | Up to 5 years |
| Overall Survival (OS) | OS is measured from the date of randomization to the date of death due to any cause. | Up to 5 years |
| MRD-negative CR Rate | MRD-negative CR is defined as the percentage of participants who achieved both CR or better and MRD negativity at a threshold of 10^-5 and 10^-6. MRD-negative CR rate will be evaluated at the first occurrence from induction treatment initiation for participants per IMWG criteria. | Up to 5 years |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity | An Adverse event (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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity of TEAEs 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 adverse events. | Up to 5 years |
| Change from baseline in Health-related quality of life (HRQoL) (symptoms and functioning) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 item instrument (EORTC-QLQ-C30) | Change from baseline in participants' HRQoL (symptoms and functioning) as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0-to-100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms. | Up to 5 years |
| San Francisco |
| California |
| 94143 |
| United States |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Peter MacCallum Cancer Centre | Melbourne | 3000 | Australia |
| The Alfred Hospital | Melbourne | 3004 | Australia |
| Instituto D Or de Pesquisa e Ensino | Salvador | 41253 190 | Brazil |
| Fundacao Antonio Prudente A C Camargo Cancer Center | São Paulo | 01509 900 | Brazil |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | São Paulo | 05652 900 | Brazil |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | 72076 | Germany |
| Universitatsklinikum Wurzburg | Würzburg | 97080 | Germany |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| 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 |
| C556306 | daratumumab |
| D000069286 | Bortezomib |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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