A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003

Phase 3RecruitingNCT07623798

Innovent Biologics (Suzhou) Co. Ltd.255 enrolled

Overview

The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd or SVd)

This study is an open, multicenter, randomized controlled phase III clinical trial aimed at evaluating the efficacy and safety of IBI3003 compared to the investigator's choice regimen (DPd or PVd or SVd) in participants with relapsed or refractory multiple myeloma who have previously received 1-4 lines of therapy and have been exposed to three classes of drugs (proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies). The plan is to enroll approximately 255 participants, who will be randomly assigned to the experimental group and the control group in a 2:1 ratio. Approximately 170 participants in the experimental group will receive IBI3003 treatment, while about 85 participants in the control group will receive the investigator's choice of treatment (DPd or PVd or SVd). Participants in the experimental group can discontinue medication for observation after meeting the criteria for stopping treatment. During the discontinuation period, if they meet the re-treatment criteria, following discussion between the investigator and the sponsor, and based on the participant's preference, IBI3003 re-treatment may be given until the criteria for terminating treatment are met.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

255

Conditions

Relapsed or Refractory Multiple Myeloma

Interventions

Pomalidomide CapsulesDRUG

1. The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg/d orally, on days 1-21; 2. The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg/d orally, on days 1-14 of each treatment cycle;

Bortezomib for InjectionDRUG

The PVd treatment regimen, with one cycle every 21 days: Bortezomib on days 1, 4, 8, and 11 of cycles 1-8, and on days 1 and 8 from cycle 9 onwards.

Daratumumab Injection (Subcutaneous Injection)DRUG

The DPd treatment regimen, one cycle every 28 days: on days 1, 8, 15, and 22 of cycles 1 and 2; on days 1 and 15 from cycles 3-6; and on day 1 from cycle 7 onwards.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria： 1. Age ≥18 years. 2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria. 3. At least one of the following measurable disease indicators: * Serum M-protein ≥ 5 g/L（For IgA and IgD subtypes, it is recommended to use quantitative immunoglobulin measurements instead of M protein） * Urine M-protein ≥200 mg/24h * Serum free light chain (FLC) test: affected FLC level ≥100 mg/L and abnormal serum FLC ratio (\<0.26 or \>1.65) 4. Life expectancy ≥3 months. 5. Fertile females and sexually active fertile males must agree to use highly effective contraception (failure rate \<1% per year) during the study and for 90 days after the last dose of the investigational drug. For participants in the clinical trial, contraceptive measures must comply with local regulations regarding the use of contraceptive methods. Females and males must agree not to donate eggs (ova, oocytes) or sperm during the study and for 90 days after the last dose of the investigational drug. 6. Willing and able to comply with the prohibitions and restrictions specified in this protocol. Exclusion Criteria： 1. Previous treatment with any BCMA-targeted therapy and any GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy are allowed to participate in the study. 2. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 3. Spinal cord compression that leads to limited self-care ability occurs within six months prior to informed consent or is expected to occur in the near future. 4. Have history of primary immunodeficiency. 5. Have history of organ transplantation. 6. Have received allogeneic hematopoietic stem cell transplantation within 6 months before the first administration of the study drug, or have received autologous stem cell transplantation within 3 months before the first administration of the study drug.

Locations (1)

ZhongShan Hospital FuDan University

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

PFS assessed by independent review committee

PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Secondary Outcomes

PFS assessed by investigator

PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Negativity rate of minimal residual disease (MRD)

Defined as the proportion of participants achieving MRD-negative status

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Sustained MRD negativity rate

Defined as the proportion of participants achieving MRD-negative status and maintaining it for at least 1 year

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

6-month MRD negativity rate.

The proportion of participants achieving a response of CR or better and MRD-negative status at 6 months post-randomization

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

12-month MRD negativity rate

The proportion of participants achieving a response of CR or better and MRD-negative status at 12 months post-randomization

Central Contacts

Haiyan Zhu

CONTACT

0512-69566088 haiyan.zhu@innoventbio.com

Data from ClinicalTrials.gov

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According to body weight

Selinexor TabletsDRUG

The SVd treatment regimen, with one cycle every 35 days: Bortezomib on days 1, 8，15，22 and 29 ，100 mg/d orally.

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Objective response rate

Objective response rate is defined as the percentage of participants who achieve PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Complete response or better rate

Complete response or better rate is defined as the percentage of participants who achieve CR or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Very good partial response or better rate

Very good partial response or better rate is defined as the percentage of participants who achieve very good partial response or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Duration of response

DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria or death due to any cause, whichever occurs first

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Time to response

Defined as the time from randomization to the date of the first tumor response assessment of PR or better among participants with a best overall response of PR or better

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Time to best response

Defined as the time from randomization to the date of first documented Best Overall Response (BOR) among participants with a best overall response of PR or better

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Time to next treatment

Defined as the time from initiation of study drug treatment to initiation of next-line therapy

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Overall survival

OS is defined as the time from the date of randomization to the date of the participant's death due to any cause

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Number of Participants with Treatment-Emergent Adverse events (TEAE) by Severity

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grading of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) according to the ASTCT consensus

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Number of Participants with Treatment-related Adverse Event (TRAE) by Severity

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Number of Participants with Adverse Event of Special Interest (AESI) by Severity

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Number of Participants with Serious Adverse Event (SAE)

Defined as the percentage of participants with SAE

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores

Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug

Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores

Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported

Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug