Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Su... | Completed
Study to Evaluate the Safety and Ef... | Completed
Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma

Trial Source

Location not identified by Google services

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Medical Conditions
  • Multiple Myeloma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01324947
Primary Trial ID Number

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Summary
The purpose of this study was to evaluate the efficacy and safety of pomalidomide monotherapy in participants with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : pomalidomide

Study Arm Groups : Pomalidomide

Intervention Type
See Interventions above
Primary Outcome Measures
    Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment; From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.
Secondary Outcome Measures
    Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment; From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.; Number of Participants With Adverse Events and Type of Adverse Events; From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.; Kaplan Meier Estimates for Progression Free Survival (PFS) by Investigator Based on IMWG; From randomization through the follow-up phase; Maximum duration of follow-up for PFS was 90.3 weeks.; Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria; From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.; Kaplan-Meier Estimate Duration of Response Based on Investigator Assessment Using IMWG Criteria; From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum duration of response follow-up was 90.3 weeks.; Kaplan-Meier Estimate for Overall Survival; From randomization through the follow-up phase; Maximum time on follow-up was 141.1 weeks.; Time to Response Based on IMWG and Assessed by the Investigator; From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    1. Subjects with refractory or relapsed and refractory multiple myeloma (MM) 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 International Myeloma Working Group (IMWG) criteria and as decided by an Independent Review Adjudication Committee (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

    Exclusion Criteria

    - The presence of any of the following will exclude a subject from enrollment:

    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 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 participants 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 Red Blood Cell (RBC) transfusion or recombinant human erythropoietin use is permitted)

    - Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST) or serum glutamic pyruvic (SGPT) / alanine aminotransferase (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 (Classification of Malignant Tumours T = Tumor size; N = Nodes lymph nodes involved; M = metastasis to other parts of the body; (TMN 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 (New York 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, which likely need additional steroid or immunosuppressive treatments in addition to the study treatment.

    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 human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B or C.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
Sheffield
S10 2JF
London
EC1A 7BE
King's College Hospital
London
SE5 9RS
Plymouth
PL6 8DH
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Musculoskeletal Department; Freeman Hospital
Newcastle upon Tyne
NE7 7DN
Nottingham
Nottinghamshire
NG5 1PB
Sutton
SM2 5PT
Royal Bournemouth Hospital
Bournemouth
Dorset
BH7 7DW
Royal Wolverhampton Hospitals Trust - Research and Development
Wolverhampton
WV10 OQP
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Italy, Netherlands, Russian Federation, Spain, Sweden, Switzerland, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Open-label, Multi-center, Single Arm Study For The Safety And Efficacy Of Pomalidomide Monotherapy For Subjects With Refractory Or Relapsed And Refractory Multiple Myeloma. A Companion Study For Clinical Trial CC-4047-MM003
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CC-4047-MM-003/C
Sponsor(s)
Celgene Corporation
Key Dates

Recruitment Start Date

May 2011

Recruitment End Date

Jul 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

27 Mar 2011

Date updated in source

19 Aug 2015