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Clinical Trials List

Protocol NumberIM048022

NCT Number(ClinicalTrials.gov Identfier)NCT05827016

Active

2023-06-02 - 2030-12-30

Phase III

Recruiting6

A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM)

Trial Applicant

BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 王銘崇無

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 裴松南無

E-DA Hospital

Co-Principal Investigator

張肇松無
蔡郁棻無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 余垣斌無

Far Eastern Memorial Hospital

Co-Principal Investigator

蔣京谷無
林世強無

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 Shang-Yi Huang 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tung-Liang Lin 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

洪玉馨無
Ming-Chung Kao 無

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Multiple Myeloma

Objectives

The purpose of this trial is to see how an experimental drug called iberdomide (also known as BMS-986382 or CC-220) performs better than lenalidomide (also known as Revlimid) when you are recovering from an autologous stem cell transplant and your doctor thinks it is helpful. How effective it is in treating multiple myeloma after continued treatment is necessary to control the myeloma. This is also called maintenance treatment. Your physician will explain whether this is appropriate for you. This trial will have two phases. In the first phase, three different dose levels of iberdomide (0.75 mg, 1 mg, and 1.3 mg) could be tested. These three dose levels of iberdomide have been tested in a small number of patients newly diagnosed with multiple myeloma. One of three iberdomide dose levels will then be selected for further testing in the second phase of the trial. "Experimental" means the drug is still under investigation and the investigating physicians are trying to learn more about it. It also means that health authorities have not approved this medicine or any of its combination medicines for use in patients, including patients with your type of cancer. This trial will test the safety and efficacy of iberdomide in a larger number of patients. This trial will also assess how you feel about receiving treatment for multiple myeloma in this trial and your quality of life as it relates to your health.

Test Drug

Iberdomide (CC-220)Revlimid (Lenalidomide) Capsules

Active Ingredient

Iberdomide
Iberdomide
Iberdomide
Iberdomide
Iberdomide
Lenalidomide
Lenalidomide
Lenalidomide

Dosage Form

Capsules
Capsules

Dosage

0.45 mg
0.6 mg
0.75 mg
1.0 mg
1.3 mg
5 mg
10 mg
15 mg

Endpoints

Comparison of iberdomide versus lenalidomide in participants with NDMM after ASCT, as measured by PFS

Inclution Criteria

Inclusion Criteria

Confirmed diagnosis of symptomatic multiple myeloma (MM).
Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria.

Exclusion Criteria

Exclusion Criteria

Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
Known central nervous system/meningeal involvement of MM.
Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.
Other protocol-defined Inclusion/Exclusion criteria apply.

The Estimated Number of Participants

Taiwan

28 participants
Global

1216 participants