Tests chidamide added to VRD in people with high-risk multiple myeloma
Tests chidamide with VRD against VRD alone in adults with high-risk multiple myeloma.
Plain-language title generated from the registry record
Registry title: Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04025450, who can take part
Where in China
- First Affiliated Hospital SooChow UniversitySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT04025450
- Record updated
- 19 July 2019
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 1.Diagnosed as multiple myeloma, and has one of the above:; 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; RISS-3; IgD/IgE MM; with measurable extra-medullary plasmacytoma; flowcytometry showed peripheral blood plasma cell ≥0.165%；; 2.Secretory MM should have measurable markers, including:; specific M protein value (≥5g/L)；; and/or involved flc ≥100mg/L；; 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: 2.Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed; 5.Allergic constitution or being allergic to any drug within the regimen of the trial; 6.With uncontrolled mental diseases; 7.With active infection; 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; 3.With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction; 1.With ≥2 degree of peripheral neuropath or with pain; 4.Patients in pregnancy or lactation; 8.With non-myeloma-associated acute renal dysfunction.