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出境医 / 临床实验 / 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

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
Multiple Myeloma Drug: Chidamide+VRD Drug: VRD 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 15, 2029
Estimated Study Completion Date : July 15, 2029
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 :
  1. complete remission rate [ Time Frame: at the time point 1 month after the last cycle ]
    complete remission rate after treated by the corresponding regimen

  2. incidence and severity of adverse events [ Time Frame: 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 :
  1. progression free survival [ Time Frame: 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

  2. overall survival [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Chengcheng Fu, PhD 13962191404 fuzhengzheng@suda.edu.cn

Locations
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China, Jiangsu
First Affiliated Hospital, Soochow University Recruiting
Suzhou, Jiangsu, China, 215000
Contact: Fu chengcheng, Phd    13962191404    fuchengcheng@suda.edu.cn   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Investigators
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Principal Investigator: chengcheng Fu, PhD First Affiliated Hospital of Suzhou University
Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 19, 2019
Estimated Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date July 15, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • complete remission rate [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • progression free survival [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Chidamide+VRD
  • 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
    Intervention: Drug: VRD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2029
Estimated Primary Completion Date July 15, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chengcheng Fu, PhD 13962191404 fuzhengzheng@suda.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025450
Other Study ID Numbers  ICMJE SZ-ChiVRD VS VRD-MM02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The First Affiliated Hospital of Soochow University
Study Sponsor  ICMJE The First Affiliated Hospital of Soochow University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: chengcheng Fu, PhD First Affiliated Hospital of Suzhou University
PRS Account The First Affiliated Hospital of Soochow University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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