Comparing Chidamide with VRD for High-Risk Multiple Myeloma

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

This study is testing if adding a new drug called chidamide to the standard treatment for high-risk multiple myeloma can help patients do better and feel safer.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT04025450 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with high-risk multiple myeloma based on specific genetic markers or disease characteristics.

Not a fit: Patients with low-risk multiple myeloma or those who do not meet the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with high-risk multiple myeloma.

How similar studies have performed: While there have been studies on VRD regimens, the combination with chidamide is a novel approach that has not been extensively tested.

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.

Where this trial is running

Suzhou, Jiangsu

• 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

Conditions: Multiple Myeloma