Status:
RECRUITING
Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, which will be determined by efficacy and safety profiles of the...
Eligibility Criteria
Inclusion
- 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%；
- 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);
- Age≥18 years, male or female;
- ECOG 0-2 points, with life expectance ≥3 months; GA score \<2;
- ALT/AST level \<2.5 times of the maximum of normal range; total bilirubin\<1.5 times of normal maximum；
- Neutrophil count≥1.5×109/L, platelet count≥50×109/L;
- eGFR≥40ml/min，except in the case of myeloma-related nephropathy;
- Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1;
- Willing to accept the possibility of potential adverse events and efficacy observation by the investigators;
- Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial.
Exclusion
- With ≥2 degree of peripheral neuropath or with pain;
- Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed;
- With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction;
- Patients in pregnancy or lactation;
- Allergic constitution or being allergic to any drug within the regimen of the trial;
- With uncontrolled mental diseases;
- With active infection;
- With non-myeloma-associated acute renal dysfunction;
- With active hepatitis;
- HIV positive;
- History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma;
- With other conditions that the investigators think unfit for the trial.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04025450
Start Date
July 15 2019
End Date
July 15 2029
Last Update
July 19 2019
Active Locations (1)
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1
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China, 215000