Clinical trial NCT03605056: Phase 2 Trial of Chidamide-Lenalidomide-Dexamethasone(CRD) Regimen in R/R MM
Official title: Chindamide in Combination With Lenalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma, a Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Chipscreen Biosciences, Ltd.
First posted: 2018-07-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the patients involved in this study will receive a 3-drug regimen (chindamide, lenalidomide and dexamethasone)
Primary purpose: TREATMENT

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


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of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care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

Primary outcomes:
measure: Response Rate
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 2 years
measure: Overall Survival Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Peng Liu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: