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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006816-10 | EudraCT Number |
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This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1: Prior BCMA antibody-drug conjugate (ADC) or chimeric antigen receptor T (CAR-T) | Experimental | Participants in Cohort A1 will be treated at the double step-up split dosing regimen. |
|
| Cohort A2: Prior BCMA Bispecific | Experimental | Participants enrolled into exploratory Cohort A2 will receive the same dosing regimen as Cohort A1. |
|
| Cohort B1: Prior BCMA CAR-T | Experimental | Participants enrolled in expansion Cohort B1, will be given cevostamab at the selected dosing regimen. |
|
| Cohort B2: Prior BCMA Bispecific | Experimental | Expansion Cohort B2 will be opened, after the initial results from Cohort A2, at the same dose as per Cohort B1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cevostamab | Drug | Cevostamab will be administered by IV infusion in 21-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Determined by the Investigator | Baseline up to approximately 2 years | |
| Percentage of Participants with Adverse Events | Baseline up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR as Determined by the Independent Review Committee (IRC) | Baseline up to approximately 2 years | |
| Duration of Response (DOR) | Baseline up to approximately 2 years | |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Residual Disease (MRD) Negative Rate | Baseline up to approximately 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045-2517 | United States | ||
| Mayo Clinic-Jacksonville |
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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| Tocilizumab | Drug | Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary. |
|
| Rate of Complete Response (CR) or Better |
| Baseline up to approximately 2 years |
| Rate of Very Good Partial Response (VGPR) or Better | Baseline up to approximately 2 years |
| Overall Survival (OS) | Baseline up until death from any cause (up to approximately 2 years) |
| Progression-free Survival (PFS) | Baseline up to approximately 2 years |
| Time to First Response (for Participants who Achieve an Objective Response) | Baseline up to approximately 2 years |
| Time to Best Response (for Participants who Achieve an Objective Response) | Baseline up to approximately 2 years |
| Percentage of Participants Experiencing a Clinically Meaningful Improvement in the Fatigue Domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core-30 Questionnaire (QLQ-C30) and EORTC QLQ-MY20 | Baseline up to approximately 2 years |
| Time to Deterioration in the Fatigue Domain of the EORTC QLQ-C30 and/or Disease Symptoms Domain of the EORTC QLQ-MY20 | Baseline up to approximately 2 years |
| Serum Concentration of Cevostamab at Specified Timepoints | At Cycles 1, 2, 3, 4, 6, 8 and every other cycle until the end of treatment up to approximately 2 years. Each cycle is 21-days. |
| Number of Anti-drug Antibody (ADAs) Against Cevostamab at Baseline | Baseline |
| Percentage of Participants with ADAs Against Cevostamab During the Study | Up to approximately 2 years |
| Cytokine Release Syndrome (CRS) Following Administration of Tocilizumab | Baseline up to approximately 2 years |
| Relationship Between Serum Concentration of Cevostamab and Cytokine Release | Baseline up to approximately 2 years |
| Relationship Between Serum Concentration of Cevostamab and T Cell Number | Baseline up to approximately 2 years |
| Relationship Between Serum Concentration of Cevostamab and T-cell Activation State | Baseline up to approximately 2 years |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Icahn School of Medicine at Mount Sinai (ISMMS) | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Tennessee Oncology - Nashville | Nashville | Tennessee | 37203 | United States |
| Hunstman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| St Vincent's Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHU NANTES - Hôtel Dieu | Nantes | 44093 | France |
| APHP - Hospital Saint Louis | Paris | 75475 | France |
| CHU de Poitiers - La Miletrie | Poitiers | 86021 | France |
| Klinik der Uni zu Köln | Cologne | 50924 | Germany |
| Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II | Hamburg | 20246 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Hadassah Ein Karem Hospital | Jerusalem | 9112001 | Israel |
| Sheba Medical Center | Ramat Gan | 5262100 | Israel |
| Sourasky Medical Centre | Tel Aviv | 6423906 | Israel |
| Policlinico S.Orsola-Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Asst Papa Giovanni Xxiii | Bergamo | Lombardy | 24127 | Italy |
| Fond. IRCCS Istituto Nazionale Tumori | Milan | Lombardy | 20133 | Italy |
| A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette | Turin | Piedmont | 10126 | Italy |
| Hospital Clínic i Provincial | Barcelona | 08036 | Spain |
| Hospital Univ. 12 de Octubre | Madrid | 28041 | 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 |
|---|---|
| C502936 | tocilizumab |
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