Comparing Chidamide with VRD for High-Risk Multiple Myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of combining chidamide with the VRD regimen (bortezomib, lenalidomide, dexamethasone) in patients with primary high-risk multiple myeloma. The study consists of two phases: the first phase involves dose escalation of chidamide to determine the optimal dosage, while the second phase compares the outcomes of patients receiving the combination treatment against those receiving the standard VRD regimen. Patients will be randomly assigned to either treatment group, and their responses will be monitored for efficacy and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Affiliated Hospital, Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: chengcheng Fu, PhD — First Affiliated Hospital of Suzhou University
• Study coordinator: Chengcheng Fu, PhD
• Email: fuzhengzheng@suda.edu.cn
• Phone: 13962191404

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.