An open-label study for the safety and efficacy of pomalidomide inrefractory or refractory/relapsed multiple myeloma subjects

Conditions: Refractory or relapsed and refractory multiple myeloma
MedDRA version: 13.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-023343-16-CZ

Lead Sponsor: Celgene Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 85

Inclusion Criteria

1. Subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in Study CC-4047-MM-003 and discontinued study therapy with dexamethasone alone (Treatment Arm B) after at least two cycles of dexamethasone treatment and due to development of documented disease progression according to the IMWG criteria and as decided by an IRAC.
2. Must be = 18 years at the time of signing the informed consent form.
3. The subject must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. The only exception is if a skeletal survey was performed within 90 days prior to the start of Cycle 1, then a new survey will not be required.
4. Must be able to adhere to the study visit schedule and other protocol requirements.
5. Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein = 1.0 g/dL or urine M-protein = 200 mg/24 hours). However, for subjects with IgA multiple myeloma, a serum M-protein of = 0.5 g/dL or urine M-protein = 200 mg/24 hours will be eligible for the study.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
7. Females of childbearing potential (FCBP) must agree to refrain from becoming pregnant for 28 days prior to initiation of study drug, while on study drug and for 28 days after discontinuation from the study drug and must agree to regular pregnancy testing during this timeframe.
8. Females must agree to abstain from breastfeeding during study participation and 28 days after study discontinuation.
9. Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy.
10. Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study treatment.
11. All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
12. All subjects must agree not to share study medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

1. Subjects with multiple myeloma who were not treated as a part of Study CC-4047-MM-003 (Arm B).
2. Subjects who received any treatments (steroids, anti-myeloma, or anti-cancer therapy) within the last 14 days of wash-out period before initiation of study treatment.
3. Subjects who discontinued CC-4047-MM-003 study =120 days.
4. Subjects who initiate another anti-myeloma therapy from the time of disease progression on study CC-4047-MM-003 to the time of treatment initiation in the companion study.
5. Any of the following laboratory abnormalities:
• Absolute neutrophil count (ANC) < 1,000/µL.
• Platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/µL for subjects in whom = 50% of bone marrow nucleated cells are plasma cells
• Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula
• Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L); or free ionized calcium > 6.5 mg/dL (> 1.6 mmol/L)
• Hemoglobin = 8 g/dL (= 4.96 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
• Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
• Serum total bilirubin > 2.0 mg/dL
6. Prior history of malignancies, other than MM, 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)
7. Hypersensitivity to thalidomide or lenalidomide
8. Peripheral neuropathy = Grade 2.
9. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant.
10. Subjects who are planning for or who are eligible for stem cell transplant.
11. Subjects with any one of the following:
• Congestive heart failure (NY Heart Association Class III or IV)
• Myocardial infarction within 12 months prior to starting study treatment
• Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
12. Subjects who received any of the following within the last 14 days of initiation of study treatment:
• Plasmapheresis
• Major surgery (kyphoplasty is not considered major surgery)
• Radiation therapy
13. Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of treatment.
14. Subjects with chronic conditions such as rheumatoid arthritis, multiple sclerosis and lupus.
15. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
16. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide.
17. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.
18. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
19. Pregnant or breastfeeding females.
20. Known HIV positivity or active infectious hepatitis A, B or C.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of pomalidomide (CC-4047) monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who discontinued from Treatment Arm B (dexamethasone alone) of Study CC-4047-MM-003 due to the development of documented disease progression during treatment.;Secondary Objective: To evaluate the safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who discontinued treatment after being treated in the dexamethasone alone arm (Treatment Arm B) in Study CC-4047-MM-003 due to the development of documented disease progression during treatment.;Primary end point(s): The primary endpoint is overall response rate (ORR) using the new International Myeloma Working Group Uniform (IMWG) response criteria. An analysis comparing the results of response assessments judged by the EMBT criteria (Blade, 1998) to those of the IMWG criteria will also be performed.;Timepoint(s) of evaluation of this end point: Time to event

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Safety (type, frequency, and severity of adverse events [AEs], and relationship of AEs to study drug)<br>• Progression-free survival (PFS)<br>• Time to progression (TTP)<br>• Duration of response<br>• Overall survival (OS)<br>;Timepoint(s) of evaluation of this end point: Time to event

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