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

Phase 1

Conditions: Refractory or relapsed and refractory multiple myeloma
MedDRA version: 16.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-023343-16-GB

Lead Sponsor: Celgene Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 74

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
starting the second cycle 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 = 0.5g/dL or urine M-protein
= 200 mg/24 hours).
6.Eastern Cooperative Oncology Group (ECOG) performance status score
of 0, 1, or 2.
7. Females of childbearing potential (FCBP†) must agree to utilize two
reliable forms of contraception simultaneously or practice true
abstinence [when this is in line with the preferred and usual lifestyle of
the subject. Periodic abstinence (e.g., calendar, ovulation,
symptothermal, post ovulation methods) and withdrawal are not
acceptable methods of contraception]from heterosexual contact for at
least 28 days before starting study drug, while participating in the study
(including dose interruptions), and for at least 28 days after study
treatment discontinuation 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 either use a latex condom during any sexual
contact with FCBP or practice true abstinence [when this is in line with
the preferred and usual lifestyle of the subject. Periodic abstinence (e.g.
calendar, ovulation, symptothermal, post-ovulation methods) and
withdrawal are not acceptable methods of contraception] 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: 0
F.1.2 Adults (18-64 years)

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 anti-myeloma, or anti-cancer therapies 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 (if creatinine clearance calculated from the 24-hour urine
sample is >=45 mL/min, patient will qualify for the trial)
•Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L);
•Hemoglobin < 8 g/dL (< 4.9 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 (34.2 µmol/L); or > 3.0 x ULN for
subjects with hereditary benign hyperbilirubinaemia
6.Prior history of malignancies, other than MM, unless the subject has
been free of the disease for = 5 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. (This includes =
Grade 3 rash during prior thalidomide or lenalidomide therapy).
8.Peripheral neuropathy = Grade 2.
9.Subjects who received an allogeneic bone marrow or allogeneic
peripheral blood stem cell transplant less than 12 months prior to
initiation of study treatment and who have not discontinued
immunosuppressive treatment for at least 4 weeks prior to initiation of
study treatment and are currently dependent on such treatment.
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 o

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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