Clinical trial · Observational
A Study of NINLARO® in Chinese Adults With Multiple Myeloma
Clinical Outcome of Ixazomib (NINLARO®) Based Regimens in Chinese Patients With Multiple Myeloma Previously Receiving a Bortezomib/Carfilzomib-Based (re)Induction Regimen in Clinical Setting of Real World: An Open-Label, Single-Arm, Multicenter, Observation Study
NCT05013190CI-TRIAL-00100403active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
The main aim of this study is to check side effects and results in adults with multiple myeloma after switching from a bortezomib/carfilzomib -based to an Ixazomib-based treatment.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants With Multiple Myeloma (MM)
- description
- Participants diagnosed with MM (newly diagnosed multiple myeloma \[NDMM\] and first relapse multiple myeloma \[FRMM\]) using International Myeloma Working Group (IMWG) criteria who received a bortezomib/carfilzomib-based triple-drug regimens for more than 2 cycles as initial therapy, achieved at least partial response (PR) as defined by IMWG criteria, and are ready to start receiving an ixazomib containing therapy prescribed by their treating physician will be observed prospectively for 24 months.
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) at 24 Months
- timeFrame
- From the date of first administration of ixazomib therapy to the date of first documentation of PD or death, lost to follow-up, whichever occurs first (up to 24 months)
- description
- PFS:time date of first administration of ixazomib therapy to date of first documentation of progressive disease(PD)/death,lost to follow-up,whichever occurs first as per IMWG 2016 Response Criteria.PD:increase of 25 percent(%) from lowest confirmed response value in any one/more of following:Serum and Urine M-protein only in participants without measurable serum and urine M-protein levels,difference between involved/uninvolved free light chain (FLC) levels(absolute increase greater than(\>)10 milligram per deciliter \[mg/dL\]),and without measurable involved FLC levels, bone marrow plasma-cell% irrespective of baseline status (absolute increase must be ≥10%); appearance of new lesions, ≥50% increase from nadir in SPD of \>1 lesion/ ≥50% increase in the longest diameter of a previous lesion \>1 centimeter in short axis; ≥50% increase in circulating plasma cells (minimum of 200 cells per microliter \[mcL\]) if this is the only measure of disease. It will be analyzed using Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Who was first diagnosed or first relapse MM participants using IMWG 2016 criteria. 2. Diagnosed with multiple myeloma using IMWG 2016 criteria and must be transplant ineligible as determined by their physician, or if transplant eligible, not expect to undergo transplant for at least 24 months after study enrollment. a. Stem cell harvest and mobilization regimen is acceptable if clinically indicated. But must first be confirmed by the Takeda Medical Monitor. 3. Who received bortezomib/carfilzomib-based triple-drug regimens as frontline treatment, including bortezomib+cyclophosphamide+dexamethasone (VCD), bortezomib+lenalidomide dexamethasone (VRD), bortezomib+doxorubicin+dexamethasone (PAD), bortezomib+thalidomide+dexamethasone (VTD), bortezomib+pomadomide+dexamethasone (VPD), or carfilzomib+lenalidomide+dexamethasone (KRD), carfilzomib+thalidomide+dexamethasone (KTD), carfilzomib+pomalidomide+dexamethasone (KPD). 4. Must achieve at least partial response (PR) as defined by IMWG criteria after bortezomib/carfilzomib-based initial therapy. 5. Eastern Cooperative Oncology Group (ECOG) 0-2. Exclusion Criteria: 1. Received a bortezomib/carfilzomib-based triple-drug regimens as initial therapy less than 2 cycles. 2. Failure to have fully recovered (that is, less than or equal to \[\<=\] Grade 1 toxicity) from the reversible effects of prior chemotherapy. 3. Have documented diagnosis of other cancers prior to the diagnosis of MM, excluding squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, which is considered cured with minimal risk of recurrence within 3 years. 4. Has \>=Grade 2 peripheral neuropathy (PN), or Grade 1 with pain on clinical examination at the time of enrollment. 5. Previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not. 6. Have gastrointestinal (GI) disease or procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing. 7. Have an active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.
References
Publications (1)
- DERIVEDChen W, Liu A, Li L. The MODIFY Study Protocol: An Open-Label, Single-Arm, Multicenter, Prospective Pragmatic Study of Ixazomib-Based Triple-Drug Therapy in Chinese Patients with Multiple Myeloma. Adv Ther. 2023 Feb;40(2):705-717. doi: 10.1007/s12325-022-02355-3. Epub 2022 Dec 4. PMID 36463561