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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524028-23-00 | EU Trial (CTIS) Number |
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The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cevostamab + Pomalidomide + Dexamethasone | Experimental | Cevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards. Pomalidomide will be administered orally (PO) on a 28-day cycle from cycle 2 onwards. Dexamethasone will be administered as a premedication prior to cevostamab. |
|
| Standard of Care (SOC) | Active Comparator | Participants will receive investigator's choice of one SOC regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cevostamab | Drug | Participants will receive cevostamab IV as per the schedule given in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate | Up to 1 year after the last participant is randomized | |
| Progression-Free Survival (PFS) | Up to 5 years after the last participant is randomized |
| Measure | Description | Time Frame |
|---|---|---|
| Very Good Partial Response (VGPR) or Better Rate | Up to 5 years after the last participant is randomized | |
| Overall Survival (OS) | Up to 5 years after the last participant is randomized | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: CO46096 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Recruiting | Duarte | California | 91010-3012 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Pomalidomide | Drug | Participants will receive pomalidomide tablet orally PO as per the schedule given in the protocol. |
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| Dexamethasone | Drug | Participants will receive dexamethasone tablet orally PO or IV as per the schedule given in the protocol. |
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| Daratumumab | Drug | Participants will receive daratumumab SC as per the schedule given in the protocol. |
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| Elotuzumab | Drug | Participants will receive elotuzumab IV as per the schedule given in the protocol. |
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| Carfilzomib | Drug | Participants will receive carfilzomib IV as per the schedule given in the protocol. |
|
| Time to Confirmed Deterioration in the Disease Symptoms Scale as Assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Multiple Myeloma Module 20 (MY20) |
Primary domains: fatigue, pain, physical functioning, cognitive functioning and global health status. |
| Up to 5 years after the last participant is randomized |
| Overall Response Rate (ORR) | Up to 5 years after the last participant is randomized |
| Complete Response (CR) Rate | Up to 5 years after the last participant is randomized |
| Time to Response (TTR) | Up to 5 years after the last participant is randomized |
| Time to Best Response (TTBR) | Up to 5 years after the last participant is randomized |
| Duration of Response (DOR) | Up to 5 years after the last participant is randomized |
| Progression-Free Survival (PFS) | Up to 5 years after the last participant is randomized |
| Progression-Free Survival 2 (PFS2) | Up to 5 years after the last participant is randomized |
| Overall MRD-Negative Complete Response Rate | Up to 5 years after the last participant is randomized |
| Overall MRD-Negative Rate | Up to 5 years after the last participant is randomized |
| Sustained MRD-Negative CR Rate | At 6, 12, and 24 months |
| Percentage of Participants With Adverse Events (AEs) | Up to 5 years after the last participant is randomized |
| Tolerability as Assessed by the Incidence of Dose Interruptions, Dose Reductions, Dose Intensity, and Treatment Discontinuation | Up to 5 years after the last participant is randomized |
| Number of Participants With Presence, Frequency of Occurrence, Severity, and/or Degree of Interference With Daily Function of Shortness of Breath, Cough, Heart Palpitations, Rash, Dizziness, and Nausea Assessed NCI PRO-CTCAE | Up to 5 years after the last participant is randomized |
| Change From Baseline in Shortness of Breath, Cough, Heart Palpitations, Rash, Dizziness, and Nausea Assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) | Baseline and up to 5 years after the last participant is randomized |
| Change From Cycle 1 Day 8 in Treatment-Related Side Effect Bother as Assessed by the Functional Assessment of Cancer Therapy-General, General Population 5 (FACTG GP5) | At Day 8 of Cycle 1, up to 5 years after the last participant is randomized. Cycle 1 is 21 days. |
| Change From Baseline in the Disease Symptom Scale of the EORTC QLQ-MY20 | Baseline and Up to 5 years after the last participant is randomized |
| Change from Baseline in the Global Health Status/Quality of Life (GHS/QoL) of the EORTC QLQ-Core 30 (C30) | Baseline and Up to 5 years after the last participant is randomized |
| Time to Confirmed Deterioration in GHS/QoL as Assessed by the EORTC QLQ-C30 | Up to 5 years after the last participant is randomized |
| Change From Baseline in Fatigue as Assessed by the EORTC QLQ-C30 | Baseline and up to 5 years after the last participant is randomized |
| Time to Confirmed Deterioration in Fatigue as Assessed by the EORTC QLQ-C30 | Up to 5 years after the last participant is randomized |
| Percentage of Participants Experiencing Clinically Meaningful Improvement in Disease Symptoms as Assessed by the EORTC QLQ-MY20 | Up to 5 years after the last participant is randomized |
| Percentage of Participants Experiencing Clinically Meaningful Improvement in GHS/QoL as Assessed by the EORTC QLQ-C30 | Up to 5 years after the last participant is randomized |
| Percentage of Participants Experiencing Clinically Meaningful Improvement in Fatigue as Assessed by the EORTC QLQ-C30 | Up to 5 years after the last participant is randomized |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline and with ADAs to Cevostamab During the Study | Baseline and up to 5 years after the last participant is randomized |
| City of Hope - Lennar Foundation Cancer Center |
| Recruiting |
| Irvine |
| California |
| 92618 |
| United States |
| Emory University Hospital Midtown | Recruiting | Atlanta | Georgia | 30308 | United States |
| Novant Health Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
| Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| TriHealth Cancer and Blood Institute | Recruiting | Cincinnati | Ohio | 45220 | United States |
| Auxilio Mutuo Cancer Center | Recruiting | San Juan | 917 | Puerto Rico |
| 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 |
|---|---|
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| C556306 | daratumumab |
| C546027 | elotuzumab |
| C524865 | carfilzomib |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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