Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients

NCT04025450 | Recruiting Phase 1

• 1 other identifier: SZ-ChiVRD VS VRD-MM02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• complete remission rate

  complete remission rate after treated by the corresponding regimen

  at the time point 1 month after the last cycle

• incidence and severity of adverse events

  any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure

  from the date of the start of treatment to 36 months after last patient's enrollment

Secondary Outcomes (2)

• progression free survival

  from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment;

• overall survival

  from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment

Study Arms (2)

Chidamide plus VRD

EXPERIMENTAL

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

Drug: Chidamide+VRD

VRD

ACTIVE COMPARATOR

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

Interventions

Chidamide+VRD DRUG

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

Chidamide plus VRD

VRD DRUG

Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14

VRD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%；
• 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);
• Age≥18 years, male or female;
• ECOG 0-2 points, with life expectance ≥3 months; GA score \<2;
• ALT/AST level \<2.5 times of the maximum of normal range; total bilirubin\<1.5 times of normal maximum；
• Neutrophil count≥1.5×109/L, platelet count≥50×109/L;
• eGFR≥40ml/min，except in the case of myeloma-related nephropathy;

You may not qualify if:

• With ≥2 degree of peripheral neuropath or with pain;
• Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed;
• With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction;
• Patients in pregnancy or lactation;
• Allergic constitution or being allergic to any drug within the regimen of the trial;
• With uncontrolled mental diseases;
• With active infection;
• With non-myeloma-associated acute renal dysfunction;
• With active hepatitis;
• HIV positive;
• History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma;
• With other conditions that the investigators think unfit for the trial.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• chengcheng Fu, PhD

  First Affiliated Hospital of Suzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengcheng Fu, PhD

CONTACT

13962191404; fuzhengzheng@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: July 15, 2019
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): July 15, 2029
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

CN (1)