NCT04025450 Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
| NCT ID | NCT04025450 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2019-07-15 |
| Primary Completion | 2029-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2019-07-15 with a primary completion date of 2029-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
chengcheng Fu, PhD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Suzhou University
Frequently Asked Questions
Who can join the NCT04025450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04025450 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04025450 currently recruiting?
Yes, NCT04025450 is actively recruiting participants. Contact the research team at fuzhengzheng@suda.edu.cn for enrollment information.
Where is the NCT04025450 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT04025450 clinical trial?
NCT04025450 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is chengcheng Fu, PhD at First Affiliated Hospital of Suzhou University. The trial plans to enroll 50 participants.