A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Patients With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study (NIMBUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01311687
First received: March 8, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.


Condition Intervention Phase
Multiple Myeloma
Drug: pomalidomide
Drug: dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: From randomization until the data cut-off date of 07 September 2012. Maximum duration of follow-up for PFS assessments was 57 weeks. ] [ Designated as safety issue: No ]

    Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.

    Progressive disease requires 1 of the following:

    • Increase of ≥ 25% from nadir in:

      • Serum M-component (absolute increase ≥ 0.5 g/dl);
      • Urine M-component (absolute increase ≥ 200 mg/24 hours);
      • Bone marrow plasma cell percentage (absolute % ≥ 10%);
    • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;
    • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease.

  • Progression-free Survival (PFS) With a Later Cut-off Date [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum duration of follow-up for PFS assessments was 74 weeks. ] [ Designated as safety issue: No ]

    Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.

    Progressive disease requires 1 of the following:

    • Increase of ≥ 25% from nadir in:

      • Serum M-component (absolute increase ≥ 0.5 g/dl);
      • Urine M-component (absolute increase ≥ 200 mg/24 hours);
      • Bone marrow plasma cell percentage (absolute % ≥ 10%);
    • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;
    • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 01 March 2013. Maximum time on treatment was 93 weeks. ] [ Designated as safety issue: Yes ]

    An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:

    • Results in death;
    • Is life-threatening;
    • Requires or prolongs existing inpatient hospitalization;
    • Results in persistent or significant disability/incapacity;
    • Is a congenital anomaly/birth defect;
    • Constitutes an important medical event.

    The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):

    Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.


  • Overall Survival [ Time Frame: From randomization until the data cut-off date of 07 September 2012. Maximum time on follow-up for survival was 70 weeks. ] [ Designated as safety issue: No ]
    Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

  • Overall Survival With a Later Cut-off Date [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up for survival was 93 weeks. ] [ Designated as safety issue: No ]
    Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

  • Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. ] [ Designated as safety issue: No ]

    Objective response is defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the Independent Response Adjudication Committee:

    SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.


  • Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. ] [ Designated as safety issue: No ]

    Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the Independent Response Adjudication Committee:

    CR requires all of the following:

    • Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days.
    • <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed.
    • No increase in size or number of lytic bone lesions.
    • Disappearance of soft tissue plasmacytomas.

    PR requires all of the following:

    • ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days.
    • Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days.
    • For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days.
    • ≥ 50% reduction in the size of soft tissue plasmacytomas.
    • No increase in size or number of lytic bone lesions.

  • Time to Progression [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. ] [ Designated as safety issue: No ]

    Time to progression (TTP) is calculated as the time from randomization to the first documented progression confirmed by a blinded, independent Response Adjudication Committee and based on the International Myeloma Working Group Uniform Response criteria (IMWG).

    Progressive disease requires 1 of the following:

    • Increase of ≥ 25% from nadir in:

      • Serum M-component (absolute increase ≥ 0.5 g/dl);
      • Urine M-component (absolute increase ≥ 200 mg/24 hours);
      • Bone marrow plasma cell percentage (absolute % ≥ 10%);
    • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;
    • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease.

  • Time to Response [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. ] [ Designated as safety issue: No ]

    Time to response is calculated as the time from randomization to the initial documented response (partial response or better) based on IMWG criteria.

    SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.


  • Duration of Response [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. ] [ Designated as safety issue: No ]
    Duration of response (calculated for responders only) is defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria assessed by the Independent Response Adjudication Committee.

  • Time to the First Hemoglobin Improvement [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. ] [ Designated as safety issue: No ]

    Time to increased hemoglobin, defined as the time from randomization to at least one category improvement from Baseline in common terminology criteria for adverse events (CTCAE) grade for hemoglobin level. Hemoglobin categories are:

    1. Normal;
    2. CTCAE Grade 1: < lower limit of normal (LLN) to 10.0 g/dL;
    3. CTCAE Grade 2: < 10.0 to <8.0 g/dL.

    Participants with CTCAE Grade 3 anemia or worse at Baseline were excluded from the study.


  • Time to Improvement in Bone Pain [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. ] [ Designated as safety issue: No ]

    Time to improvement in bone pain is defined as the time from randomization to at least one category improvement from Baseline in bone pain category.

    Bone pain was categorized (from best to worst) according to answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for patients with Multiple Myeloma Module (QLQ-MY20), Question 1, "Have you had bone aches or pain?":

    1. Not at all,
    2. A little,
    3. Quite a bit, or
    4. Very much.

  • Time to Improvement in Renal Function [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. ] [ Designated as safety issue: No ]

    Time to improvement in renal function is defined as the time from randomization to at least one category improvement from Baseline in renal function.

    Renal Function was categorized as (from best to worst):

    1. Normal: creatinine clearance ≥80 mL/min;
    2. Grade 1: creatinine clearance ≥60 to <80 mL/min;
    3. Grade 2 : creatinine clearance ≥45 to < 60 mL/min.

    Participants with creatinine clearance < 45 mL/min at baseline were be excluded from the study.


  • Time to Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks. ] [ Designated as safety issue: No ]

    Time to improvement in ECOG performance status defined as the time from randomization until at least a one category improvement from Baseline in ECOG performance status score.

    The categories of the ECOG Performance Status Scale are as follows:

    • 0: Fully active, able to carry on all pre-disease performance without restriction;
    • 1: Restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, e.g., light housework, office work;
    • 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

    Patients with a score of 3, 4 or 5 were excluded from participating in the study.


  • Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain [ Time Frame: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]

    The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).

    The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement.


  • Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain [ Time Frame: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]

    The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).

    The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.


  • Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain [ Time Frame: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]

    The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).

    The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.


  • Change From Baseline in the EORTC QLQ-C30 Fatigue Domain [ Time Frame: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]

    The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).

    The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).


  • Change From Baseline in the EORTC QLQ-C30 Pain Domain [ Time Frame: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]

    The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).

    The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reductions in pain (i.e. improvement in symptom) and positive values indicate increases in pain (i.e. worsening of symptom).


  • Change From Baseline in the European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms [ Time Frame: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]

    The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective).

    The EORTC QLQ-MY20 Disease Symptoms Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction (i.e. improvement) in symptoms and positive values indicate increase (i.e. worsening) of symptoms.


  • Change From Baseline in the EORTC QLQ-MY20 Side Effects Domain [ Time Frame: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]

    The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective).

    The EORTC QLQ-MY20 Side Effects Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction in side effects (i.e.improvement in symptom) and positive values indicate increase in side effects (i.e. worsening of symptom).


  • Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Utility Index Score [ Time Frame: Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]
    EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where an EQ-5D score of 1.00 equals "perfect health" and a score of 0 equals "death". A positive change from Baseline score indicates improvement in health status.

  • Time to First Worsening of Quality of Life (QOL) Domains [ Time Frame: Assessed on Day 1 of the first 6 treatment cycles. ] [ Designated as safety issue: No ]

    Time to worsening in quality of life domains was calculated as the time from Baseline to the first worsened minimally important difference (MID), defined as the smallest change in a QOL score considered important to patients that would lead the patient or clinician to consider a change in therapy. MID thresholds were calculated in Standard Error of Measurement (SEM) units using the Baseline QOL data. Based on the MID, participants were classified as worsened according to the following:

    For the EORTC QLQ-C30 global health status and functional scales and the EQ-5D health utility score, participants were classified as worsened if their change from Baseline score was less than -1 SEM.

    For the EORTC QLQ-C30 symptom scores (fatigue and pain) and EORTC QLQ-MY20 disease symptoms and side effects scales, participants were classified as worsened if their change from Baseline score was greater than 1 SEM.

    See previous outcome measures for definitions of each scale.



Enrollment: 455
Study Start Date: March 2011
Estimated Study Completion Date: August 2017
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pomalidomide plus Low-Dose Dexamethasone

Participants ≤ 75 years of age received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle until disease progression and 40 mg dexamethasone administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.

Participants > 75 years of age received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle until disease progression and 20 mg dexamethasone administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.

Drug: pomalidomide
4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle until disease progression
Other Names:
  • Pomalyst®
  • CC-4047
Drug: dexamethasone
Dexamethasone tablets for oral administration
Active Comparator: High-Dose Dexamethasone

Participants ≤ 75 years of age received 40 mg dexamethasone administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.

Participants > 75 years of age received 20 mg dexamethasone administered by mouth once per day on Days 1 through 4, 9 through 7, and 17 through 20 of a 28-day cycle until disease progression.

Drug: dexamethasone
Dexamethasone tablets for oral administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be ≥ 18 years of age
  • Subjects must have documented diagnosis of multiple myeloma and have measurable disease
  • Subjects must have undergone prior treatment with ≥ 2 treatment lines of anti-myeloma therapy
  • Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy
  • All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib
  • All subjects must have failed treatment with both lenalidomide and bortezomib in one of the following ways: 1) Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or bortezomib, or 2) In case of prior response [≥ partial response (PR)] to lenalidomide or bortezomib, subjects must have relapsed within 6 months after stopping treatment with lenalidomide and/or bortezomib-containing regimens, or 3) Subjects who have not had a ≥ minimal response (MR) and have developed intolerance/toxicity after a minimum of two cycles of lenalidomide- and/or bortezomib-containing regimen
  • Patients must have received adequate prior alkylator therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • 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
  • Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation
  • Males must agree to use a latex condom during any sexual during the study and for 28 days following discontinuation from this study
  • 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:

  • 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
    • Creatinine Clearance < 45 mL/min
    • Corrected serum calcium > 14 mg/dL
    • Hemoglobin ≤ 8 g/dL
    • Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST) or transaminase, serum glutamic pyruvic (SGPT)/ alanine aminotransferase (ALT) > 3.0 x upper limit of normal (ULN)
    • Serum total bilirubin > 2.0 mg/dL
  • Previous therapy with pomalidomide
  • Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
  • Resistance to high-dose dexamethasone used in the last line of therapy
  • Peripheral neuropathy ≥ Grade 2
  • Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
  • Subjects who are planning for or who are eligible for stem cell transplant
  • 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
  • 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, 4) Use of any anti-myeloma drug therapy
  • Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
  • Subjects with conditions requiring chronic steroid or immunosuppressive treatment
  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  • Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
  • Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
  • Pregnant or breastfeeding females
  • Known Human Immunodeficiency Virus (HIV) positivity or active infectious hepatitis A, B or C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311687

  Show 92 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Mohamed Zaki, MD, PhD Celgene Corporation
  More Information

Publications:
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01311687     History of Changes
Other Study ID Numbers: CC-4047-MM-003, 2010-019820-30
Study First Received: March 8, 2011
Results First Received: March 28, 2014
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Celgene Corporation:
Myeloma
Multiple Myeloma
Relapsed Multiple Myeloma
Relapsed and Refractory Multiple Myeloma
Refractory Myeloma
Resistant Multiple Myeloma
Treatment-resistant Multiple Myeloma
Pomalidomide
Lenalidomide-resistant
Bortezomib-resistant

Additional relevant MeSH terms:
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 acetate
Dexamethasone
Dexamethasone 21-phosphate
Pomalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on August 20, 2014