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Clinical Trials List

Protocol NumberR5458-ONC-2245
NCT Number(ClinicalTrials.gov Identfier)NCT05730036

2023-05-01 - 2034-07-31

Phase III

Recruiting11

An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Hung Chang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王銘崇 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tzeon-jye Chiou Division of Hematology & Oncology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Yi Huang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HSIN-CHEN LIN Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳宇欽 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃威翰 Division of Hematology & Oncology
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Feng Cho Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林炫聿 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jen Liu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Relapsed Refractory Multiple Myeloma (RRMM)

Objectives

The primary objective of this trial was to compare progression-free survival (PFS), as assessed by an independent review committee (IRC), between participants receiving linvoseltamab monotherapy and EPd. Key secondary purposes are: ‧ Comparison of antitumor activity as assessed by IRC between linvoseltamab monotherapy and EPd, as measured by o Objective response o ?Excellent Partial Response (VGPR) o ?Complete response (CR) ‧ Comparing the incidence of minimal residual disease (MRD)-negative status in bone marrow (10-5) between linvoseltamab monotherapy and EPd ‧ Comparison of overall survival (OS) between linvoseltamab monotherapy and EPd ‧ To evaluate the efficacy of linvoseltamab monotherapy and EPd in ​​the treatment of pain symptoms Other secondary purposes include: ‧ Evaluate the safety and tolerability of linvoseltamab monotherapy compared with EPd ‧ Compare PFS as assessed by trial moderators between participants receiving linvoseltamab monotherapy versus EPd. ‧ Comparison of antitumor activity as assessed by trial moderators between linvoseltamab monotherapy and EPd, as measured by o Objective response o ?VGPR o ?CR ‧ Assessing duration of response (DOR) as assessed by the trial moderator and IRC for participants who achieved an objective response while receiving linvoseltamab monotherapy and receiving EPd ‧ Assessing duration of MRD-negative status in bone marrow in participants receiving linvoseltamab monotherapy and EPd ‧ Evaluating participants who achieved a PR response and time to response for linvoseltamab monotherapy and EPd ‧ Evaluate the pharmacokinetics (PK) of linvoseltamab ‧ Evaluating the immunogenicity of linvoseltamab ‧ To evaluate the effect of linvoseltamab monotherapy versus EPd on patient-rated quality of life (QoL), function, and symptoms

Test Drug

Linvoseltamab

Active Ingredient

Linvoseltamab

Dosage Form

Sterile solution

Dosage

10 mg/mL

Endpoints

To compare progression-free survival (PFS) as assessed by an independent review committee (IRC) between participants receiving linvoseltamab monotherapy and EPd.

Inclution Criteria

Key Inclusion Criteria:

Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.
Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.

Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.

Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
Adequate hematologic, hepatic, renal and cardiac function, as well as evidence of adequate bone marrow reserves
Life expectancy of at least 6 months

Exclusion Criteria

Key Exclusion Criteria:

Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
Prior treatment with elotuzumab and/or pomalidomide
Participants with known MM brain lesions or meningeal involvement
Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder.
Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol.

The Estimated Number of Participants

  • Taiwan

    52 participants

  • Global

    380 participants

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