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Trial record 1 of 1 for:    NCT04557150
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A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of RO7425781 in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)

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
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. RO7425781 will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of RO7425781 (Part 1) and a randomized dose expansion of RO7425781 (Part 2).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: RO7425781 Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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.
 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 104 weeks ]
  2. Percentage of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 Day 1 up to Cycle 1 Day 21 ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 104 weeks ]
  2. Duration of Response (DOR) [ Time Frame: Up to 104 weeks ]
  3. Progression-Free Survival (PFS) [ Time Frame: Up to 104 weeks ]
  4. Overall Survival (OS) [ Time Frame: Up to 104 weeks ]
  5. Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7425781 [ Time Frame: Up to 104 weeks ]
  6. Maximum Concentration (Cmax) of RO7425781 [ Time Frame: Up to 104 weeks ]
  7. Time of Maximum Concentration (Tmax) of RO7425781 [ Time Frame: Up to 104 weeks ]
  8. Minimum Concentration (Cmin) of RO7425781 [ Time Frame: Up to 104 weeks ]
  9. SC Bioavailability (F) of RO7425781 [ Time Frame: Up to 104 weeks ]
  10. Apparent Clearance (CL/F) of RO7425781 [ Time Frame: Up to 104 weeks ]
  11. Volume of Distribution at Steady State (Vss) of RO7425781 (IV only) [ Time Frame: Up to 104 weeks ]
  12. Area Under the Curve (AUC) at Various Time Intervals of RO7425781 [ Time Frame: Up to 104 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Reference Study ID Number: BP42233 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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