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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04557150 |
Recruitment Status :
Recruiting
First Posted : September 21, 2020
Last Update Posted : May 30, 2023
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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 : | 400 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 : | June 25, 2025 |
Estimated Study Completion Date : | June 25, 2025 |

Arm | Intervention/treatment |
---|---|
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 RP2Ds 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, respectively, will be initiated at the Recommended Phase 2 Doses (RP2Ds) determined in Part I: Dose Escalation phase.
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Drug: RO7425781
RO7425781 will be administered via IV/SC administration. The RP2Ds 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 104 weeks ]
- Percentage of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 Day 1 up to Cycle 1 Day 21 ]
- Objective Response Rate (ORR) [ Time Frame: Up to 104 weeks ]
- Duration of Response (DOR) [ Time Frame: Up to 104 weeks ]
- Progression-Free Survival (PFS) [ Time Frame: Up to 104 weeks ]
- Overall Survival (OS) [ Time Frame: Up to 104 weeks ]
- Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7425781 [ Time Frame: Up to 104 weeks ]
- Maximum Concentration (Cmax) of RO7425781 [ Time Frame: Up to 104 weeks ]
- Time of Maximum Concentration (Tmax) of RO7425781 [ Time Frame: Up to 104 weeks ]
- Minimum Concentration (Cmin) of RO7425781 [ Time Frame: Up to 104 weeks ]
- SC Bioavailability (F) of RO7425781 [ Time Frame: Up to 104 weeks ]
- Apparent Clearance (CL/F) of RO7425781 [ Time Frame: Up to 104 weeks ]
- Volume of Distribution at Steady State (Vss) of RO7425781 (IV only) [ Time Frame: Up to 104 weeks ]
- Area Under the Curve (AUC) at Various Time Intervals of RO7425781 [ Time Frame: Up to 104 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 and Dose Expansion 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.
- 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 for MM treatment 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, 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 infusion and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication.
- Prior solid organ transplantation.
- Active auto-immune disease or flare within 6 months prior to start of study treatment
- 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 |
North Melbourne, Victoria, Australia, 3051 | |
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 | Recruiting |
Lille, France, 59037 | |
CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique | Active, not 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 | |
Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli" | Recruiting |
Bologna, Emilia-Romagna, Italy, 40138 | |
Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia | 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 30, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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 |