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

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ClinicalTrials.gov Identifier: NCT02916420
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Pomalidomide Drug: Dexamethasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone in Chinese Patients With Relapsed and Refractory Multiple Myeloma
Study Start Date : September 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Treatment
Pomalidomide plus low-dose Dexamethasone
Drug: Pomalidomide
4mg/day, d1-d21, 28 days per cycle

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




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: up to 2 years ]
  2. Duration of Response [ Time Frame: up to 2 years ]
  3. Time to Response [ Time Frame: up to 2 years ]
  4. Overall Survival [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

      1. 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
      2. 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
      3. 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

Exclusion Criteria:

  • 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
  • Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
  • Previous therapy with pomalidomide
  • Peripheral neuropathy ≥ Grade 2
  • Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
  • Subjects who received any of the following within the last 14 days of initiation of study treatment: plasmapheresis, major surgery, radiation therapy, or use of any anti-myeloma drug therapy
  • Use of any investigational drugs within 28 days prior to enrollment
  • Subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis, and lupus, etc.
  • Patients unable or unwilling to undergo antithrombotic prophylactic treatment
  • Subjects who received an allogeneic hematopoietic stem cell transplant less than 12 months prior to enrollment
  • Subjects who are planning for or eligible for hematopoietic stem cell transplant
  • Pregnant or lactating females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916420


Contacts
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Contact: Lugui Qiu, MD 86-022-27218738 qiulg@ihcams.ac.cn

Locations
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China
Blood Diseases Hospital Chinese Academy of Medical Sciences Recruiting
Tianjin, China
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Lugui Qiu, MD Blood Diseases Hospital Chinese Academy of Medical Sciences

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Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02916420     History of Changes
Other Study ID Numbers: SIM-135-Ⅲ
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Pomalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents