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NCT01311687 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2018-10-24

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival (PFS) - Primary Analysis

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outcome · POSTED

Progression-free Survival (PFS) With a Later Cut-off Date

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outcome · POSTED

Number of Participants With Adverse Events (AEs)

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outcome · POSTED

Overall Survival - Primary Analysis

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outcome · POSTED

Overall Survival With a Later Cut-off Date

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outcome · POSTED

Overall Survival Based on the Final Dataset

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outcome · POSTED

Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria

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outcome · POSTED

Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria

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outcome · POSTED

Time to Progression

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outcome · POSTED

Time to Response

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outcome · POSTED

Duration of Response

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outcome · POSTED

Time to the First Hemoglobin Improvement

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outcome · POSTED

Time to Improvement in Bone Pain

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outcome · POSTED

Time to Improvement in Renal Function

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outcome · POSTED

Time to Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status

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outcome · POSTED

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

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Fatigue Domain

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outcome · POSTED

Change From Baseline in the EORTC QLQ-C30 Pain Domain

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outcome · POSTED

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

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outcome · POSTED

Change From Baseline in the EORTC QLQ-MY20 Side Effects Domain

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outcome · POSTED

Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Utility Index Score

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outcome · POSTED

Time to First Worsening of Quality of Life (QOL) Domains

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants received 4 mg pomalidomide administered by mouth on Days 1 to 21 of each 28-day treatment cycle and 40 mg dexamethasone (or 20 mg for participants \> 75 years of age) administered by mouth once per day on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression.
    intervention Names
    1. Drug: pomalidomide
    2. Drug: Dexamethasone
    label
    Pomalidomide + Low-Dose Dexamethasone
    type
    EXPERIMENTAL
  2. description
    Participants received 40 mg dexamethasone (or 20 mg for participants \> 75 years of age) administered by mouth once per day on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day treatment cycle until disease progression.
    intervention Names
    1. Drug: Dexamethasone
    label
    High-Dose Dexamethasone
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Pomalidomide + Low-Dose Dexamethasone
    description
    4 mg pomalidomide capsules administered orally
    name
    pomalidomide
    other Names
    1. CC-4047
    2. Pomalyst®
    type
    DRUG
  2. arm Group Labels
    1. High-Dose Dexamethasone
    2. Pomalidomide + Low-Dose Dexamethasone
    description
    40 mg dexamethasone (or 20 mg for participants \> 75 years of age) tablets administered orally
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
455
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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 required 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o 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.
    measure
    Progression-free Survival (PFS) - Primary Analysis
    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.
  2. description
    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: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o 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.
    measure
    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.
secondary Outcomes
  1. description
    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.
    measure
    Number of Participants With Adverse Events (AEs)
    time Frame
    From first dose of study drug through to 30 days after the last dose as of the end of the study (29 August 2017); maximum time on treatment was 297, 269, and 239 weeks in the Pomalidomide + LD-Dex, HD-Dex, and cross-over groups respectively.
  2. description
    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.
    measure
    Overall Survival - Primary Analysis
    time Frame
    From randomization until the data cut-off date of 07 September 2012. Maximum time on follow-up for survival was 70 weeks.
  3. description
    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.
    measure
    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.
  4. description
    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.
    measure
    Overall Survival Based on the Final Dataset
    time Frame
    From randomization until the data cut-off date of 29 August 2017. Maximum time on follow-up for survival was 324 weeks.
  5. description
    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.
    measure
    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.
  6. description
    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.
    measure
    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.
  7. description
    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: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o 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.
    measure
    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.
  8. description
    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.
    measure
    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.
  9. description
    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.
    measure
    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.
  10. description
    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.
    measure
    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.
  11. description
    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.
    measure
    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.
  12. description
    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): - Normal: creatinine clearance ≥80 mL/min; - Grade 1: creatinine clearance ≥60 to \<80 mL/min; - Grade 2 : creatinine clearance ≥45 to \< 60 mL/min. Participants with creatinine clearance \< 45 mL/min at baseline were excluded from the study.
    measure
    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.
Full study description
brief Summary
The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.
Source references
references
  1. citation
    Moreau P, Weisel KC, Song KW, Gibson CJ, Saunders O, Sternas LA, Hong K, Zaki MH, Dimopoulos MA. Relationship of response and survival in patients with relapsed and refractory multiple myeloma treated with pomalidomide plus low-dose dexamethasone in the MM-003 trial randomized phase III trial (NIMBUS). Leuk Lymphoma. 2016 Dec;57(12):2839-2847. doi: 10.1080/10428194.2016.1180685. Epub 2016 May 13.
    pmid
    27173785
    type
    RESULT
  2. citation
    Miguel JS, Weisel K, Moreau P, Lacy M, Song K, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Belch A, Palumbo A, Schey S, Sonneveld P, Yu X, Sternas L, Jacques C, Zaki M, Dimopoulos M. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1055-1066. doi: 10.1016/S1470-2045(13)70380-2. Epub 2013 Sep 3.
    pmid
    24007748
    type
    RESULT
  3. citation
    Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.
    pmid
    27267105
    type
    DERIVED
  4. citation
    Weisel KC, Dimopoulos MA, Moreau P, Lacy MQ, Song KW, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Knop S, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel J. Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma. Haematologica. 2016 Jul;101(7):872-8. doi: 10.3324/haematol.2015.137083. Epub 2016 Apr 14.
    pmid
    27081177
    type
    DERIVED
  5. citation
    Dimopoulos MA, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Spencer A, Knop S, Bahlis NJ, Renner C, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel JF. Cytogenetics and long-term survival of patients with refractory or relapsed and refractory multiple myeloma treated with pomalidomide and low-dose dexamethasone. Haematologica. 2015 Oct;100(10):1327-33. doi: 10.3324/haematol.2014.117077. Epub 2015 Aug 6.
    pmid
    26250580
    type
    DERIVED
  6. citation
    San Miguel JF, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Renner C, Bahlis NJ, Yu X, Teasdale T, Sternas L, Jacques C, Zaki MH, Dimopoulos MA. Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma. Haematologica. 2015 Oct;100(10):1334-9. doi: 10.3324/haematol.2015.125864. Epub 2015 Jul 9.
    pmid
    26160879
    type
    DERIVED
  7. citation
    Weisel K, Dimopoulos M, Song KW, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Gibson CJ, Zaki M, Jacques C, San Miguel J. Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial. Clin Lymphoma Myeloma Leuk. 2015 Sep;15(9):519-30. doi: 10.1016/j.clml.2015.05.007. Epub 2015 Jun 6.
    pmid
    26149712
    type
    DERIVED
  8. citation
    Song KW, Dimopoulos MA, Weisel KC, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Monzini MS, Zaki M, Jacques C, San Miguel J. Health-related quality of life from the MM-003 trial of pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed and/or refractory multiple myeloma. Haematologica. 2015 Feb;100(2):e63-7. doi: 10.3324/haematol.2014.112557. Epub 2014 Nov 25. No abstract available.
    pmid
    25425684
    type
    DERIVED
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