Clinical trial · Interventional
A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003
A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma
NCT07623798CI-TRIAL-00113426recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib for Injection | Drug | Bortezomib | ALIAS |
| Daratumumab Injection (Subcutaneous Injection) | Drug | Daratumumab | ALIAS |
| IBI3003 | Drug | — | UNRESOLVED |
| Pomalidomide Capsules | Drug | Pomalidomide | ALIAS |
| Selinexor Tablets | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- the investigator's choice regimen (DPd or PVd or SVd)
- description
- participants will receive DPd or PVd or SVd until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.
- interventionNames
- Drug: Pomalidomide Capsules
- Drug: Bortezomib for Injection
- Drug: Daratumumab Injection (Subcutaneous Injection)
- Drug: Selinexor Tablets
- type
- EXPERIMENTAL
- label
- IBI3003
- description
- participants will receive IBI3003 until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.
- interventionNames
- Drug: IBI3003
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.