Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
Study Details
Study Description
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 will be compared with that of VRD regimen.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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 patients; afterward, the optimal dosage of chidamide will be combined with VRD regimen, patients will be randomly assigned to chidamide+VRD group or VRD group, and their efficacy and safety will be compared.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Chidamide plus VRD 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 |
Drug: Chidamide+VRD
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
|
| Active Comparator: VRD Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14 |
Drug: VRD
Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
|
Outcome Measures
Primary Outcome Measures
- complete remission rate [at the time point 1 month after the last cycle]
complete remission rate after treated by the corresponding regimen
- incidence and severity of adverse events [from the date of the start of treatment to 36 months after last patient's enrollment]
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Secondary Outcome Measures
- progression free survival [from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment;]
from date of inclusion to date of progression, relapse, or death from any cause
- overall survival [from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment]
from the date of inclusion to date of death, irrespective of cause
Eligibility Criteria
Criteria
Inclusion Criteria:
- 1.Diagnosed as multiple myeloma, and has one of the above:
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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;
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RISS-3;
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IgD/IgE MM;
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with measurable extra-medullary plasmacytoma;
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flowcytometry showed peripheral blood plasma cell ≥0.165%；
- 2.Secretory MM should have measurable markers, including:
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specific M protein value (≥5g/L)；
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and/or involved flc ≥100mg/L；
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and/or measurable extramedullary foci (diameter>1cm on CT);
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3.Age≥18 years, male or female;
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4.ECOG 0-2 points, with life expectance ≥3 months; GA score <2;
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5.ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of normal maximum；
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6.Neutrophil count≥1.5×109/L, platelet count≥50×109/L;
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7.eGFR≥40ml/min，except in the case of myeloma-related nephropathy;
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8.Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1;
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9.Willing to accept the possibility of potential adverse events and efficacy observation by the investigators;
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10.Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial.
Exclusion Criteria:
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1.With ≥2 degree of peripheral neuropath or with pain;
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2.Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed;
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3.With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction;
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4.Patients in pregnancy or lactation;
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5.Allergic constitution or being allergic to any drug within the regimen of the trial;
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6.With uncontrolled mental diseases;
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7.With active infection;
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8.With non-myeloma-associated acute renal dysfunction;
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9.With active hepatitis;
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10.HIV positive;
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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;
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12.With other conditions that the investigators think unfit for the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital, Soochow University | Suzhou | Jiangsu | China | 215000 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
Investigators
- Principal Investigator: chengcheng Fu, PhD, First Affiliated Hospital of Suzhou University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SZ-ChiVRD VS VRD-MM02