Clinical trial · Interventional
Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients, a Phase I/II, Multiple Center, Randomized Clinical Trial
NCT04025450CI-TRIAL-00039589recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, in the phase II trial, the safety and efficacy of chidamide+VRD will be compared with that of VRD regimen.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide+VRD | Drug | — | UNRESOLVED |
| VRD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chidamide plus VRD
- description
- Chidamide:30mg d0,d3,d7,d10/Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
- interventionNames
- Drug: Chidamide+VRD
- type
- ACTIVE_COMPARATOR
- label
- VRD
- description
- Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
- interventionNames
- Drug: VRD
Primary outcomes (2)
- measure
- complete remission rate
- timeFrame
- at the time point 1 month after the last cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Diagnosed as multiple myeloma, and has one of the above: 1. high risk karyotype, such as 17p-,t(4;14),t(14;16),t(14;20)或1q gain,1p-, double hit myeloma, triple hit myeloma, etc; 2. RISS-3; 3. IgD/IgE MM; 4. with measurable extra-medullary plasmacytoma; 5. flowcytometry showed peripheral blood plasma cell ≥0.165%; * 2.Secretory MM should have measurable markers, including: 1. specific M protein value (≥5g/L); 2. and/or involved flc ≥100mg/L; 3. and/or measurable extramedullary foci (diameter\>1cm on CT); * 3.Age≥18 years, male or female; * 4.ECOG 0-2 points, with life expectance ≥3 months; GA score \<2; * 5.ALT/AST level \<2.5 times of the maximum of normal range; total bilirubin\<1.5 times of normal maximum; * 6.Neutrophil count≥1.5×109/L, platelet count≥50×109/L; * 7.eGFR≥40ml/min,except in the case of myeloma-related nephropathy; * 8.Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1; * 9.Willing to accept the possibility of potential adverse events and efficacy observation by the investigators; * 10.Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial. Exclusion Criteria: * 1.With ≥2 degree of peripheral neuropath or with pain; * 2.Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed; * 3.With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction; * 4.Patients in pregnancy or lactation; * 5.Allergic constitution or being allergic to any drug within the regimen of the trial; * 6.With uncontrolled mental diseases; * 7.With active infection; * 8.With non-myeloma-associated acute renal dysfunction; * 9.With active hepatitis; * 10.HIV positive; * 11.History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma; * 12.With other conditions that the investigators think unfit for the trial.
References
Publications (0)
Data not yet available
No reference posted for this study.