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Clinical Trials List

Protocol NumberCC-220-MM-002
NCT Number(ClinicalTrials.gov Identfier)NCT04975997
Active

2021-11-01 - 2030-12-01

Phase III

Recruiting7

ICD-10C90.00

Multiple myeloma not having achieved remission

ICD-10C90.02

Multiple myeloma in relapse

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9203.00

Multiple myeloma, without mention of remission

A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tung-Liang Lin Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical 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 Tsai-Yun Chen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Multiple Myeloma

Objectives

Primary Objectives: ● To compare the efficacy of Iberdomide, daratumumab, and dexamethasone (IberDd) and daratumumab, bortezomib, and dexamethasone (DVd) in subjects with recurrent partial circumvallate (RRMM) based on progression-free survival (PFS). Secondary Objectives: ● To determine the optimal dosage of iberdomide in combination with dexamethasone and daratumumab in Phase 1 to proceed to Phase 2 of the trial. ● To evaluate the pharmacokinetics (PK) of iberdomide in combination with daratumumab and dexamethasone in Phase 1. ● To evaluate the overall survival (OS) of RRMM patients treated with IberDd compared to those treated with DVd. ● To evaluate the efficacy of IberDd in RRMM patients who achieved a complete response (CR) or better compared to those treated with DVd. Achievement rate of negative minimal residual disease (MRD) status in subjects ● Assess additional efficacy parameters in RRMM subjects treated with IberDd compared to those treated with DVd ● Assess the safety of IberDd compared to DVd in RRMM subjects ● Assess the cancer-related symptoms and health-related quality of life (HRQoL) in RRMM subjects treated with IberDd compared to those treated with DVd using the European Organisation for Research and Treatment of Cancer – 30 Core Questionnaires on Quality of Life (EORTC QLQ-C30) and the European Quality of Life Multiple Myeloma Unit (EORTC QLQ-MY20). Exploratory Objectives: ● In Phase 1, assess the benefit-risk score achieved by iberdomide at different dose levels in RRMM subjects treated with IberDd ● In Phase 1, assess the efficacy of iberdomide at different dose levels in RRMM subjects treated with IberDd Relationship between genomic, molecular, and immunobiomarker status and clinical outcomes in subjects: ● Assess the persistence of MRD negativity in RRMM subjects treated with IberDd compared to those treated with DVd. ● Assess the relationship between genomic, molecular, immunobiomarker, SARS-CoV-2 serological status and clinical outcomes in RRMM subjects treated with IberDd compared to those treated with DVd. ● Assess the pharmacokinetic (PK) of iberdomide at a selected dose in combination with daratumumab and dexamethasone (IberDd). ● Assess the overall health status and utility of RRMM subjects treated with IberDd compared to those treated with DVd using the European Five Dimensions of Quality of Life Scale (EQ-5D-5L). ● Compare the utilization of healthcare resources in RRMM subjects treated with IberDd compared to those treated with DVd.

Test Drug

膠囊劑
皮下注射劑
錠劑
凍晶注射劑及懸浮注射液

Active Ingredient

Iberdomide
Daratumumab
Dexamethasone
Bortezomib

Dosage Form

130
220
110
24A

Dosage

MG
ML

Endpoints

The primary efficacy endpoint is progression-free survival (PFS), which is calculated from the date of randomization to the date of the first recorded evidence of progression or death from any cause, whichever comes first.

Inclution Criteria

Inclusion Criteria

Documented diagnosis of multiple myeloma (MM) and measurable disease.
Received 1 to 2 prior lines of anti-myeloma therapy.
Must have documented disease progression during or after their last anti-myeloma regimen.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

Exclusion Criteria

Exclusion Criteria

Any condition that confounds the ability to interpret data from the study.
Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
Known central nervous system involvement with MM.
Prior therapy with iberdomide.
Other protocol-defined Inclusion/Exclusion criteria apply.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    864 participants

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