Phase 2 Trial of Chidamide-Lenalidomide-Dexamethasone(CRD) Regimen in R/R MM

NCT03605056 | Unknown Phase 2

• 1 other identifier: SHZS-MM001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of combination of Chidamide-Lenalidomine-Dexamethasone in relapsed or refractory multiple myeloma patients

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Response Rate

  according to IMWG criteria, including the rate of complete remission (CR), very good partial remission (VGPR) and partial remission (PR)

  2 years

Secondary Outcomes (2)

• Number of participants with treatment-related adverse events

  2 years

• Overall Survival Rate

  2 years

Study Arms (1)

CRD regimen

EXPERIMENTAL

CRD is a new 3-drug regimen adding a HDACi named chidamide to a novel 2-drug combination of lenalidomide and dexamethasone (RD)

Drug: chidamide; Drug: lenalidomide; Drug: dexamethasone

Interventions

chidamide DRUG

20 mg/d, will be administered orally, on Days 1, 4, 8, 11 of each 21 day cycle

Also known as: Epidaza, CS055, HBI-8000

CRD regimen

lenalidomide DRUG

25 mg/d, will be administered orally on Days 1-14 each 21 day cycle

CRD regimen

dexamethasone DRUG

40mg weekly, will be administered orally or intravenously

CRD regimen

Eligibility Criteria

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

You may qualify if:

• Male or female patient ≥ age 18 years
• Patient is able to understand and has given voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
• Patient has been previously diagnosed with MM based on standard International Myeloma Working Group (IMWG) criteria and currently requires treatment.
• Patient must have received at least one previous line of therapy for multiple myeloma including bortezomib
• Patient must have demonstrated disease progression on or within 60 days of completion of the last therapy. Patient has measurable disease defined as at least one of the following:
• Serum M protein ≥ 0.5 g/dL (≥5 g/L)
• Urine M protein ≥200 mg/24 hours
• Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Negative serum or urine pregnancy test for women of child-bearing potential
• Screening Laboratory parameters:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/dL (1.5 x 10\^9/L). Granulocyte colony-stimulating factor (GCSF) is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
• Platelet count ≥ 70,000 cells/dL (70 x 10\^9/L) Platelet transfusion is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
• Hemoglobin ≥ 8.0 g/dl ( red blood cell (RBC) transfusions are permitted during the screening period)
• Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) ; Aspartate transaminase (AST, or SGOT) and alanine transaminase (ALT, or SGPT) ≤ 2.5x ULN Estimated creatinine clearance by Cockcroft-Gault formula ≥ 50 mL/min

You may not qualify if:

• Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy.
• Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
• Prior anti-cancer therapy within 14 days.
• Patient has any Grade 3 or \> unresolved peripheral neuropathy from previous treatment.
• Patient is human immunodeficiency virus (HIV) positive,.
• Patient is Hepatitis B Surface antigen-positive or HBV-DNA copies \> 10\^3/ml
• Patient has active hepatitis C infection.
• Hypersensitivity to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs
• Known history of allergy to 2 or \> drugs or any component of regimen
• Any clinically significant, uncontrolled medical conditions that, in the treating Investigator's opinion, would impose excessive risk to the patient or may interfere with compliance or interpretation of the study results. Uncontrolled intercurrent illness may include, but is not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations as determined by treating investigator that would limit compliance with study requirements.

Sponsors & Collaborators

• Peng Liu: lead
• Chipscreen Biosciences, Ltd.: collaborator

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; HBI-8000; Lenalidomide; Dexamethasone

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Peng Liu, MD,PhD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Wei, MD

CONTACT

00862164041990; wei.zheng@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: All the patients involved in this study will receive a 3-drug regimen (chindamide, lenalidomide and dexamethasone)

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: July 30, 2018
• Study Start: July 31, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2022
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

CN (1)