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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000238-33 | EudraCT Number | ||
| 2023-507019-36-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Agent Cevostamab (Arm A) | Experimental | Cohort A1S is a safety run-in arm evaluating cevostamab administered in 28-day cycles on a modified weekly schedule. Cohort A1E, an expansion cohort, has been opened and finished enrolling participants. Participants will be treated with single-agent cevostamab administered in 28-day cycles on a modified weekly schedule. |
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| Cevostamab plus Pomalidomide and Dexamethasone (Pd) (Arm B) | Experimental | Participants will be treated with cevostamab monotherapy during a 14-day period prior to the start of pomalidomide treatment (cevostamab pre-phase). Cohort B1S is a safety run-in arm evaluating cevostamab and Pd administered in 28-day cycles every 2 weeks (Q2W) followed by every 4 weeks (Q4W) schedule. Additional safety run-in cohort(s) with lower target dose levels of cevostamab may be opened prior to opening the expansion cohorts. Two target dose levels of target dose level 1 (DL1) and lower dose level -1 (DL-1) of cevostamab will be selected for randomization in expansion cohorts (Cohorts B1E and B3E). An additional non-randomized expansion cohort (Cohort B4E) will be included. Expansion cohorts will follow the same Q2W/Q4W dosing schedule as Cohort B1S. |
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| Cevostamab plus Daratumumab and Dexamethasone (Dd) (Arm C) | Experimental | Cohort C1S is a safety run-in arm evaluating cevostamab and Dd administered in 21 day cycles from Cycle(C)1 - C8 every 3 weeks (Q3W) and 28-day cycles from C9 onwards Q4W. Additional safety run-in cohort(s) with lower target dose levels of cevostamab may be opened prior to opening the expansion cohorts. Two target dose levels of DL1 and DL-1 of cevostamab will be selected for randomization in expansion cohorts. Expansion cohorts will follow the same Q3W/Q4W dosing schedule as Cohort C1S. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cevostamab | Drug | Cevostamab will be administered intravenously on a 28-day cycle, up to a total of 13 cycles (Arm A), in 28-day cycles Q2W followed by Q4W (Arm B) and in 21 day cycles from C1-C8 Q3W and 28-day cycles from C9 onwards Q4W (Arm C). For Arm A, participants have the option to enter re-treatment within 12 months of the end of treatment visit. For Arms B and C, participants can be treated until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase II Dose (RP2D) | Baseline up to approximately 4 years | |
| Percentage of Participants with Adverse Events | Baseline up to approximately 4 years | |
| Percentage of Dose Interruptions | Baseline up to approximately 4 years | |
| Percentage of Dose Reductions | Baseline up to approximately 4 years | |
| Percentage of Dose Intensity | Baseline up to approximately 4 years | |
| Percentage of Treatment Discontinuation | Baseline up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Baseline up to approximately 4 years | |
| Complete Response/Stringent Complete Response (CR/sCR) Rate | Baseline up to approximately 4 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| City of Hope - Lennar Foundation Cancer Center |
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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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| Tocilizumab | Drug | Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary. |
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| Pomalidomide | Drug | Pomalidomide will be administered orally (PO) on a 28-day cycle. |
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| Daratumumab | Drug | Daratumumab will be administered subcutaneously (SC) on 21 day (C1-8) and 28-day cycles (C9 onwards). |
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| Dexamethasone | Drug | Arm A: Dexamethasone will be administered as a premedication. Arms B and C: Dexamethasone will be administered via IV or orally at 20 mg as study investigational medicinal product. |
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| Rate of Very Good Partial Response (VGPR) or Better |
| Baseline up to approximately 4 years |
| Progression-free Survival (PFS) | Start of study treatment to first date of disease progression or death from any cause, whichever occurs first (up to approximately 4 years) |
| Duration of Response (DOR) | From first partial response (PR) or better until the first date of disease progression or death from any cause, whichever occurs first (up to approximately 4 years) |
| Time to First Response (for Participants who Achieve a Response of Partial Response (PR) or Better) | Baseline up to approximately 4 years |
| Time to Best Response (for Participants who Achieve a Response of PR or Better) | Baseline up to approximately 4 years |
| Overall Survival (OS) | Baseline up until death from any cause (up to approximately 4 years) |
| Serum Concentration of Cevostamab at Specified Timepoints | Cevostamab Pre-Phase (CPP) Day (D) 1 up to approximately 3 years |
| Total Exposure (Area Under the Concentration-time Curve [AUC]) of Cevostamab | CPP D1 up to approximately 4 years |
| Maximum Observed Serum Concentration (Cmax) of Cevostamab | CPP D1 up to approximately 4 years |
| Minimum Observed Serum Concentration (Cmin) of Cevostamab | CPP D1 up to approximately 4 years |
| Clearance of Cevostamab | CPP D1 up to approximately 4 years |
| Volume of Distribution at Steady State of Cevostamab | CPP D1 up to approximately 4 years |
| Number of Anti-drug Antibody (ADAs) Against Cevostamab at Baseline | Baseline |
| Percentage of Participants with ADAs Against Cevostamab During the Study | Up to approximately 4 years |
| Serum Concentration of Pomalidomide | From Cycle 1 Day 1 through Cycle 6 Day 15. Each cycle=28 days |
| Serum Concentration of Daratumumab | From C1D1 until disease progression or unexpected toxicity. Cycles 1-8 are 21 days and Cycle 9 onward are 28 days. |
| Irvine |
| California |
| 92618 |
| United States |
| Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center | Denver | Colorado | 80218 | United States |
| Karmanos Cancer Institute. | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3002 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| Fakultni Nemocnice Ostrava | Ostrava | 708 52 | Czechia |
| Rigshospitalet | København Ø | 2100 | Denmark |
| CHU de Poitiers - La Miletrie | Poitiers | 86021 | France |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Asst Papa Giovanni Xxiii | Bergamo | Lombardy | 24127 | Italy |
| A.O. Spedali Civili Di Brescia-P.O. Spedali Civili | Brescia | Lombardy | 25123 | Italy |
| Yamagata University Hospital | Yamagata | 990-9585 | Japan |
| Pratia Onkologia Katowice | Katowice | 41-500 | Poland |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28009 | Spain |
| University College London Hospitals NHS Foundation Trust | London | W1T 7HA | United Kingdom |
| Royal Marsden Hospital | Sutton | SW3 6JJ | 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 |
|---|---|
| C502936 | tocilizumab |
| C467566 | pomalidomide |
| C556306 | daratumumab |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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