A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
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ClinicalTrials.gov Identifier: NCT04557150 |
Recruitment Status :
Recruiting
First Posted : September 21, 2020
Last Update Posted : May 17, 2022
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Condition or disease | Intervention/treatment | Phase |
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Multiple Myeloma | Drug: RO7425781 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma |
Actual Study Start Date : | November 11, 2020 |
Estimated Primary Completion Date : | July 13, 2022 |
Estimated Study Completion Date : | July 13, 2022 |

Arm | Intervention/treatment |
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Experimental: Part I: Dose Escalation
Participants will receive RO7425781 as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.
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Drug: RO7425781
RO7425781 will be administered via IV/SC administration. The MTD/RP2D determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. RO7425781 will be administered as per the dosing schedule defined in Part I. |
Experimental: Part II: Dose Expansion
Dose Expansion cohorts with IV and/or SC administration will be initiated at the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) determined from Part I: Dose Escalation.
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Drug: RO7425781
RO7425781 will be administered via IV/SC administration. The MTD/RP2D determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. RO7425781 will be administered as per the dosing schedule defined in Part I. |
- Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 69 weeks ]
- Percentage of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 69 weeks ]
- Objective Response Rate (ORR) [ Time Frame: Up to 69 weeks ]
- Duration of Response (DOR) [ Time Frame: Up to 69 weeks ]
- Progression-Free Survival (PFS) [ Time Frame: Up to 69 weeks ]
- Overall Survival (OS) [ Time Frame: Up to 69 weeks ]
- Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7425781 [ Time Frame: Up to 69 weeks ]
- Maximum concentration (Cmax) of RO7425781 [ Time Frame: Up to 69 weeks ]
- Time of Maximum concentration (Tmax) of RO7425781 [ Time Frame: Up to 69 weeks ]
- Minimum concentration (Cmin) of RO7425781 [ Time Frame: Up to 69 weeks ]
- SC Bioavailability (F) of RO7425781 [ Time Frame: Up to 69 weeks ]
- Apparent Clearance (CL/F) of RO7425781 [ Time Frame: Up to 69 weeks ]
- Volume of distribution at steady state (Vss) of RO7425781 (IV only) [ Time Frame: Up to 69 weeks ]
- Area under the curve (AUC) at various time intervals of RO7425781 [ Time Frame: Up to 69 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.
- Dose Escalation Phase: Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to or have no other option for standard-of-care treatment according to the Investigator.
- Dose Expansion Phase: Participants with r/r MM who have received at least three prior treatments and are refractory to an IMiD, a PI, and a CD38-targeted therapy.
- Life expectancy of at least 12 weeks.
- Agreement to provide protocol-specific biopsy material.
- AEs from prior anti-cancer therapy resolved to Grade =<1.
- Measurable disease.
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.
- For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.
Exclusion Criteria:
- Inability to comply with protocol-mandated hospitalization and activities restrictions.
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of study drug.
- Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 2 weeks before first RO7425781 administration.
- Prior treatment with systemic immunotherapeutic agents within 2 weeks before first RO7425781 administration.
- Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.
- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks except for alkylating agents (e.g., melphalan) within 28 days, prior to first RO7425781 administration. Limited field palliative radiotherapy for bone pain or for soft tissue lesions is allowed.
- Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to first RO7425781 administration and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication.
- Prior solid organ transplantation.
- Any medical condition or abnormality in clinical laboratory tests that, in the Investigator's or Medical Monitor's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557150
Contact: Reference Study ID Number: BP42233 https://forpatients.roche.com/ | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com |
Australia, Victoria | |
Peter MacCallum Cancer Center | Recruiting |
East Melbourne, Victoria, Australia, 3002 | |
Belgium | |
UZ Gent | Recruiting |
Gent, Belgium, 9000 | |
Denmark | |
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT | Recruiting |
København Ø, Denmark, 2100 | |
France | |
CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang | Active, not recruiting |
Lille, France, 59037 | |
CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique | Recruiting |
Nantes, France, 44093 | |
Hopital De Haut Leveque; Hematologie Clinique | Recruiting |
Pessac, France, 33604 | |
Italy | |
IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica | Active, not recruiting |
Napoli, Campania, Italy, 80131 | |
Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia | Active, not recruiting |
Milano, Lombardia, Italy, 20133 | |
Instituto Clinico Humanitas; Med Onc & Hemat | Active, not recruiting |
Rozzano, Lombardia, Italy, 20089 | |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Asan Medical Center | Withdrawn |
Seoul, Korea, Republic of, 05505 | |
Spain | |
Hospital Universitario Marques de Valdecilla; Servicio de Hematologia | Active, not recruiting |
Santander, Cantabria, Spain, 39008 | |
Clinica Universitaria de Navarra; Servicio de Hematologia | Recruiting |
Pamplona, Navarra, Spain, 31008 | |
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia | Recruiting |
Salamanca, Spain, 37007 | |
United Kingdom | |
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility | Recruiting |
London, United Kingdom, W1T 7HA |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT04557150 |
Other Study ID Numbers: |
BP42233 2020-002012-46 ( EudraCT Number ) |
First Posted: | September 21, 2020 Key Record Dates |
Last Update Posted: | May 17, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |