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

Chindamide in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma, a Phase II Trial

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

Study Overview

• Status: Unknown
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: chidamide; Drug: lenalidomide; Drug: dexamethasone

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRD regimen; 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; 20 mg/d, will be administered orally, on Days 1, 4, 8, 11 of each 21 day cycle; Other Names: HBI-8000; Epidaza; CS055; Drug: lenalidomide; 25 mg/d, will be administered orally on Days 1-14 each 21 day cycle; Drug: dexamethasone; 40mg weekly, will be administered orally or intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	as assessed by CTCAE v4.0	2 years
Overall Survival Rate	The percentage of people in the study group who are still alive 2 years after the start of treatment	2 years

Collaborators and Investigators

• Sponsor: Peng Liu
• Collaborators: Chipscreen Biosciences, Ltd.
• Investigators: Principal Investigator: Peng Liu, MD,PhD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 31, 2018
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: July 21, 2018
• First Submitted That Met QC Criteria: July 21, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 21, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Lenalidomide
• Other Study ID Numbers: SHZS-MM001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No