Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone in Chinese Patients With Relapsed and Refractory Multiple Myeloma

NCT02916420 | Unknown Phase 3

• 1 other identifier: SIM-135-Ⅲ
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the efficacy and safety of pomalidomide in combination with low-dose dexamethasone in Chinese patients with relapsed and refractory multiple myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  up to 2 years

Secondary Outcomes (4)

• Progression-free Survival

  up to 2 years

• Duration of Response

  up to 2 years

• Time to Response

  up to 2 years

• Overall Survival

  up to 2 years

Study Arms (1)

Treatment

EXPERIMENTAL

Pomalidomide plus low-dose Dexamethasone

Drug: Pomalidomide; Drug: Dexamethasone

Interventions

Pomalidomide DRUG

4mg/day, d1-d21, 28 days per cycle

Treatment

Dexamethasone DRUG

≤70 years,40mg/day; \>70 years,20mg/day, d1、d8、d15、d22, 28 days per cycle

Treatment

Eligibility Criteria

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

You may qualify if:

• Have a documented diagnosis of multiple myeloma
• Subjects must have received at least 2 prior therapies. Subjects must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen). Subjects must also have documented evidence of progressive disease(PD) during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry.
• Subjects must have measurable disease: serum M-protein ≥ 5 g/L or urine M-protein ≥ 200 mg/24 hours or the involved free light chain being ≥100 mg/L when serum free light chain ratio (κ/λ ratio \< 0.26 or \> 1.65) is abnormal
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
• Life expectancy \>3 months
• For female patients,
• naturally postmenopausal for at least 24 months, or take surgical sterilization
• Women of childbearing potential must:
• have 2 negative pregnancy tests before initiating pomalidomide. The first test should be performed within 10-14 days, and the second test within 24 hours prior to initiating pomalidomide
• commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating pomalidomide treatment, during therapy, and continuing for 4 weeks following discontinuation of pomalidomide therapy
• agree to perform the pregnancy testing during the study
• Male patients must always use a condom during any sexual contact with females of reproductive potential while taking pomalidomide and for up to 4 weeks after discontinuing pomalidomide, even if they have undergone a successful vasectomy. Meanwhile male patients taking pomalidomide must not donate sperm.
• Subjects agree not to share medication with another person
• Subjects are able to adhere to the study visit schedule and other protocol requirements

You may not qualify if:

• Any serious medical conditions, laboratory abnormality, or psychiatric illness that would prevent the patient from complying to the protocol or put the patient's safety at risk
• Evidence of uncontrolled cardiovascular disease, such as congestive heart failure, unstable angina, myocardial infarction within 12 months prior to enrollment
• Any of the following laboratory abnormalities:
• ANC \< 1×10\^9/L
• PLT \< 75×10\^9/L for subjects in whom \<50% of bone marrow nucleated cells are plasma cells; or PLT \< 30×10\^9/L for subjects in whom ≥50% of bone marrow nucleated cells are plasma cells
• Creatinine Clearance \< 45 mL/min
• AST or ALT \> 3.0 x ULN
• Serum total bilirubin \> 34.2 μmol/L
• Corrected serum calcium \> 3.5 mmol/L
• Hemoglobin \< 80g/L
• Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following:
• Basal or Squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix or breast
• Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
• Serious, uncontrolled medical conditions or active infection, including but not limited to HIV antibody positive, HBsAg positive and HBV DNA copies \> 1 × 10\^3, hepatitis C virus antibody positive, uncontrolled diabetes, patients requiring hemodialysis

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomide; 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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Lugui Qiu, MD

  Blood Diseases Hospital Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lugui Qiu, MD

CONTACT

86-022-27218738; qiulg@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2016
• First Posted: September 27, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: November 2, 2016

Record last verified: 2016-10

Locations

CN (1)