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Health Condition(s) or Problem
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Multiple Myeloma
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Lay Summary
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The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy
in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in
study CC-4047-MM-003 and discontinued treatment with high-dose dexamethasone due to disease
progression.
(from ClinicalTrials.gov)
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Who can enter the trial
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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 after disease progression.
2. Must be = 18 years of age
3. Subjects must have documented diagnosis of multiple myeloma and have measurable
disease
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
5. Females of childbearing potential (FCBP) must not become pregnant for 28 days prior
to initiation of study drug, during the study, and for 28 days after discontinuation
6. Females must agree to abstain from breastfeeding during study participation and 28
days after study discontinuation.
7. Males must agree to use a latex condom during any sexual contact during the study and
for 28 days following discontinuation from this study
8. Males must also agree to refrain from donating semen or sperm while on pomalidomide
and for 28 days after discontinuation from this study.
Exclusion Criteria
1. Subjects with multiple myeloma who were not treated as a part of Study CC-4047-MM-003
(high dose dexamethasone).
2. Subjects who received any treatments (steroids, anti-myeloma, or anti-cancer therapy)
within the last 14 days 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
- Corrected serum calcium > 14 mg/dL Hemoglobin = 8 g/dL
- SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
6. Prior history of malignancies, other than MM, unless the subject has been free of the
disease for = 3 years.
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: 1) Congestive heart failure, 2) Myocardial
infarction within 12 months prior to starting study treatment, 3) 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:1) Plasmapheresis, 2) Major surgery, 3) 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
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Who cannot enter the trial
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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 after disease progression.
2. Must be = 18 years of age
3. Subjects must have documented diagnosis of multiple myeloma and have measurable
disease
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
5. Females of childbearing potential (FCBP) must not become pregnant for 28 days prior
to initiation of study drug, during the study, and for 28 days after discontinuation
6. Females must agree to abstain from breastfeeding during study participation and 28
days after study discontinuation.
7. Males must agree to use a latex condom during any sexual contact during the study and
for 28 days following discontinuation from this study
8. Males must also agree to refrain from donating semen or sperm while on pomalidomide
and for 28 days after discontinuation from this study.
Exclusion Criteria
1. Subjects with multiple myeloma who were not treated as a part of Study CC-4047-MM-003
(high dose dexamethasone).
2. Subjects who received any treatments (steroids, anti-myeloma, or anti-cancer therapy)
within the last 14 days 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
- Corrected serum calcium > 14 mg/dL Hemoglobin = 8 g/dL
- SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
6. Prior history of malignancies, other than MM, unless the subject has been free of the
disease for = 3 years.
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: 1) Congestive heart failure, 2) Myocardial
infarction within 12 months prior to starting study treatment, 3) 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:1) Plasmapheresis, 2) Major surgery, 3) 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
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What will happen
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Drug; pomalidomide; Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity; Pomalidomide; CC-4047
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Primary aim
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Number of patients with response based on the International Myeloma Working Group (IMWG) Uniform response criteria
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Secondary Aim
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Number of patients with response based on the European Group for Blood and Marrow Transplantation (EBMT) criteria; Up to 2 years; No; Number of patients with response based on the European Group for Blood and Marrow Transplantation (EBMT) criteria; Number of participants with adverse events and type of adverse events; Up to 2 years; Yes; Number of participants with adverse events and type of adverse events; Number of patients alive or dead; Approximately 5 years; No; Number of patients alive or dead; Number of months between enrollment and disease progression based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study; Up to 5 years; No; Number of months between enrollment and disease progression based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study; Time from enrollment to the first documented progression based on the International Myeloma Working Group Uniform Response criteria (IMWG); Up to 2 years; No; Time from enrollment to the first documented progression based on the International Myeloma Working Group Uniform Response criteria (IMWG); Time from the initial documented response to confirmed disease progression; Up to 2 years; No; Time from the initial documented response to confirmed disease progression
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Bournemouth, Leeds, London, Newcastle upon Tyne, Nottingham, Plymouth, Sheffield, Sutton, Wolverhampton
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