Clinical trial NCT04025450: Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this trial, patients will be randomly assigned to chidamide+VRD group or VRD group, and then treated with the corresponding regimen, and their safety and efficacy will be evaluated.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: complete remission rate
timeFrame: at the time point 1 month after the last cycle
measure: incidence and severity of adverse events
timeFrame: from the date of the start of treatment to 36 months after last patient's enrollment
Secondary outcomes:
measure: progression free survival
timeFrame: from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment;
measure: overall survival
timeFrame: from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment
Other outcomes:
Locations:
city: Suzhou
country: China
facility: First Affiliated Hospital, Soochow University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Suzhou University
name: chengcheng Fu, PhD
role: PRINCIPAL_INVESTIGATOR
References: