| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Chidamide+VRD Drug: VRD | Phase 1 Phase 2 |
| 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 |
| 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
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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
|
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1.Diagnosed as multiple myeloma, and has one of the above:
2.Secretory MM should have measurable markers, including:
Exclusion Criteria:
| Contact: Chengcheng Fu, PhD | 13962191404 | fuzhengzheng@suda.edu.cn |
| China, Jiangsu | |
| First Affiliated Hospital, Soochow University | Recruiting |
| Suzhou, Jiangsu, China, 215000 | |
| Contact: Fu chengcheng, Phd 13962191404 fuchengcheng@suda.edu.cn | |
| 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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| 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 |
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| 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 |
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| Condition ICMJE | Multiple Myeloma | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| 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 |
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| 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 |
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| PRS Account | The First Affiliated Hospital of Soochow University | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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