BridgeMD
New treatment option for Multiple Myeloma
Official title Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
ClinicalTrials.gov ID: NCT04025450
What this study is testing
What is Chidamide+VRD?
Chidamide+VRD is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 1.Diagnosed as multiple myeloma, and has one of the above:
- 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;
- RISS-3;
- IgD/IgE MM;
- with measurable extra-medullary plasmacytoma;
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- 1.Diagnosed as multiple myeloma, and has one of the above:
- 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;
- RISS-3;
- IgD/IgE MM;
- with measurable extra-medullary plasmacytoma;
- flowcytometry showed peripheral blood plasma cell ≥0.165%；
- 2.Secretory MM should have measurable markers, including:
- specific M protein value (≥5g/L)；
- and/or involved flc ≥100mg/L；
- 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 how well it works 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.