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Multiple MyelomaPhase 3NCT01324947

Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma

A Phase 3 study testing pomalidomide in people with Multiple Myeloma, run by Celgene at 91 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
pomalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
91 sitesin 15 countries
Study dates
1 Mar 2011to 31 Jul 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 International Myeloma Working Group (IMWG) criteria and as decided by an Independent Review Adjudication Committee (IRAC).
  • Must be ≥ 18 years at the time of signing the informed consent form.
  • 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.
  • Must be able to adhere to the study visit schedule and other protocol requirements.
  • 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).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Show all 12Show fewer
  • 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.
  • Females must agree to abstain from breastfeeding during study participation and 28 days after study discontinuation.
  • 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. .
  • Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study treatment.
  • All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
  • All subjects must agree not to share study medication

Who cannot join

  • The presence of any of the following will exclude a subject from enrollment:
  • Subjects with multiple myeloma who were not treated as a part of Study CC-4047-MM-003 (Arm B).
  • Subjects who received any anti-myeloma or anti-cancer therapies within the last 14 days of wash-out period before initiation of study treatment.
  • Subjects who discontinued CC-4047-MM-003 study ≥120 days.
  • 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.
  • Any of the following laboratory abnormalities:
Show all 37Show fewer
  • 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
  • Prior history of malignancies, other than Multiple Myeloma (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)
  • Hypersensitivity to thalidomide or lenalidomide. (This includes ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy).
  • Peripheral neuropathy ≥ Grade 2.
  • 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.
  • Subjects who are planning for or who are eligible for stem cell transplant.
  • 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
  • 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
  • Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of treatment.
  • 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.
  • 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 subject from signing the informed consent form.
  • Pregnant or breastfeeding females.
  • Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B or C.

Trial locations and contacts

91 sites in 15 countries.

91 sites in 15 countries

France13 sites

  • CHU Angers - Service des maladies du sang

    Angers, 49033

  • Centre Hospitalier de la côte basque - Hematologie

    Bayonne, 64019

  • Centre Hospitalier Départemental Vendée - Onco-hematologie

    La Roche, 85925

  • CHRU de Lille - Service des maladies du sang

    Lille, 59037

  • Institut Paoli Calmette - Hematology 1

    Marseille, 13009

  • CHU Hôtel-Dieu - Hematologie

    Nantes, 44093

  • Hôpital Saint Louis - Immuno-hematologie

    Paris, 75010

  • CHU Saint Antoine - Service des maladies du sang

    Paris, 75012

  • CHRU - Hôpital du Haut Lévêque - Centre François Magendie Service des maladies du sang

    Pessac, 33604

  • Centre Hospitalier Lyon sud - Hematologie

    Pierre-Bénite, 69495

  • CHRU Hôpital Purpan - Hematologie

    Toulouse, 31059

  • Hôpital Bretonneau - Hématologie & Thérapie cellulaire

    Tours, 37044

  • CHU Nancy - Hematologie

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany10 sites

  • Universitatsklinikum Carl Gustav Carus-Medizinische Klinik und Poliklinik I

    Dresden, 01307

  • Universitätsklinikum Essen, Klinik für Hämatologie Westdeutsches Tumorzentrum

    Essen, 45122

  • Askepios Klinik Altona-Abteilung Hamatologie und Internistische Onkologie

    Hamburg, 22763

  • Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V

    Heidelberg, 69120

  • Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie

    Jena, 07740

  • Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II

    Leipzig, 04103

  • Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A

    Münster, 48149

  • Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II

    Tübingen, 72076

  • Universitätsklinikum Ulm - Klinik fur Innere Medizin III

    Ulm, 89081

  • Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

    Würzburg, 97080

Other trials in Germany

United Kingdom10 sites

  • Royal Bournemouth Hospital - Haematology

    Bournemouth, BH7 7DW

  • St James's University Hospital - Haematology

    Leeds, LS9 7TF

  • St Bartholomew's Hospital - Medical Oncology

    London, EC1A 7BE

  • King's College Hospital - Haematology Clinical Trials

    London, SE5 9RS

  • Freeman Hospital - Northern Centre for Cancer Care

    Newcastle upon Tyne, NE7 7DN

  • Nottingham City Hospital - Centre for Clinical Haematology

    Nottingham, NG5 1PB

  • Derriford Hospital - Haematology

    Plymouth, PL6 8DH

  • Royal hallamshire Hospital - Haematology

    Sheffield, S10 2JF

  • Royal Marsden NHS Foundation Trust - Haematology

    Surrey, SM2 5PT

  • Royal Wolverhampton Hospitals Trust - Research and Development

    Wolverhampton, WV10 OQP

Other trials in United Kingdom

Australia9 sites

  • Royal Adelaide Hospital - SA Pathology Haematology

    Adelaide, 5000

  • Princess Alexandra Hospital - Haematology

    Brisbane, 4102

  • Royal Prince Alfred Hospital - Institute of Haematology

    Camperdown, 2050

  • Peter McCallum Cancer Institute - Directorate of Cancer Medicine

    East Melbourne, 3002

  • Frankston Hospital-Peninsula Health - Oncology Day Unit

    Frankston, 3199

  • The Alfred Hospital - Malignant Haematology & Stem Cell Transplantation

    Melbourne, 3004

  • Calvary Mater Newcastle - Haematology

    Waratah, 2298

  • Border Medical Oncology

    Wodonga, 3690

  • Wollongong Hospital - Haematology

    Wollongong, 2500

Other trials in Australia

Italy9 sites

  • Università degli Studi di Bologna - Policlinico S. Orsola - Hematology

    Bologna, 40138

  • AO Universitaria San Martino - hematooncology

    Genova, 16132

  • Fondazione "G. Pascale" - Hematology

    Naples, 80131

  • Ospedale San Luigi AO Luigi Gonzaga - Hematology

    Orbassano, 10043

  • Universita degli Studi di Padova - Clinical & Experimental Medicine

    Padova, 35128

  • Ospedale Guglielmo da Saliceto - hematooncology

    Piacenza, 29100

  • Unità di Ematologia Arcispedale S. Maria Nuova - Haematology

    Reggio Emilia, 42100

  • Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology

    Roma, 00161

  • A.O.U. San Giovanni Battista - Hematology

    Torino, 10126

Other trials in Italy

Canada8 sites

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Royal Victoria Hospital

    Montreal, Quebec, H3A1 A1

  • Princess Margaret Hospital, University Health Network

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency, Vancouver Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Spain8 sites

  • Hospital Germans Trias i Pujol - Hematology

    Badalona, 08916

  • Hospital Clinic i Provincial de Barcelona - Hematology

    Barcelona, 08036

  • Hospital de Donostia - Hematology

    Guipúzcoa, 20014

  • Hospital de La Princesa - Hematology

    Madrid, 28006

  • Hospital 12 de Octubre - Hematology

    Madrid, 28041

  • Hospital de Salamanca - Hematology

    Salamanca, 37007

  • Hospital Universitario Marqués de Valdecilla - Hematology

    Santander, 39008

  • Hospital La Fe - Hematology

    Valencia, 46009

Other trials in Spain

Sweden5 sites

  • Sahlgrenska Hospital, University of Goteborg - Hematology

    Gothenburg, S-41345

  • Karolinska University Hospital Huddinge - Center of hematology

    Stockholm, 14152

  • Karolinska University Hospital-medicine

    Stockholm, 14186

  • Karolinska University Hospital Solna- medicine

    Stockholm, 17176

  • Overlakare Medocomcentrum - Hematology

    Uppsala, 75185

Other trials in Sweden

Denmark4 sites

  • Aalborg Sygemus - Haematology

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8000

  • Odense University Hospital

    Odense, 5000

  • Vejle Hospital - Hematology

    Vejle, 7100

Other trials in Denmark

Russia4 sites

  • Hematological Research Center under the Russian Academy of Medical Sciences - Hematology & BMT

    Moscow, 125167

  • Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology

    Moscow, 125284

  • Russian Research Institute of Hematology and Blood Transfusion - Hematology

    Saint Petersburg, 191024

  • State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology

    Saint Petersburg, 197341

Other trials in Russia

Belgium3 sites

  • UZ Gent - Hematology

    Ghent, 9000

  • University Hospital Leuven - Hematology

    Leuven, 3000

  • Cliniques Universitaires ULC de Mont-Godinne - Hematology

    Yvoir, 5530

Other trials in Belgium

Netherlands3 sites

  • VUMC - Hematology

    Amsterdam, 1081 HV

  • Erasmus Medical Center - Hematology

    Rotterdam, 3015 CE

  • University Medical Center - Hematology

    Utrecht, 3584 CX

Other trials in Netherlands

Switzerland3 sites

  • Inselspital, Institut für Medizinische Onkologie

    Bern, 3010

  • Hôpitaux Universitaire de Genève - Oncologie

    Geneva, 1211

  • Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich

    Zurich, 8091

Other trials in Switzerland

Czechia1 site

  • Charles University Hospital - Internal Medicine

    Prague, 12808

Other trials in Czechia

Greece1 site

  • University of Athens - Alexandra Hospital

    Athens, 14572

Other trials in Greece

About this study

Official 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

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 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression.

Being tested
pomalidomide
Keywords
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, Companion
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pomalidomideDrug

    Also called CC-4047

    Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity

Study groups in NCT01324947
Study groupRoleWhat they receive
PomalidomideExperimentalOral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity
Receives: Drug: pomalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment

    Objective response 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 Investigator Assessment.

    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. A ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.

    Measured: 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 outcomes (7)

  1. Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment

    Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the CR and 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.

    Measured: 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.

  2. Number of Participants With Adverse Events and Type of Adverse Events

    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

    Measured: 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.

  3. Kaplan Meier Estimates for Progression Free Survival (PFS) by Investigator Based on IMWG

    Progression-free survival was calculated as the time from randomization to disease progression as determined by the Investigator 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)
    • In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)
    • Bone marrow plasma cell percentage (absolute % ≥ 10%)
    • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.

    Measured: From randomization through the follow-up phase; Maximum duration of follow-up for PFS was 90.3 weeks.

  4. Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria

    Time to progression (TTP) was calculated as the time from randomization to the first documented progression confirmed by the investigator 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)
    • In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)
    • 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.

    Measured: 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.

  5. Kaplan-Meier Estimate Duration of Response Based on Investigator Assessment Using IMWG Criteria

    Duration of Response (calculated for responders only) is defined as the time from the initial documented response (partial response or better) to confirmed disease progression by the investigator based on IMWG criteria.

    Measured: 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.

  6. Kaplan-Meier Estimate for Overall Survival

    Overall survival was 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.

    Measured: From randomization through the follow-up phase; Maximum time on follow-up was 141.1 weeks.

  7. Time to Response Based on IMWG and Assessed by the Investigator

    Time to Response was calculated as the time from enrollment to the initial response (PR or better) based on IMWG and assessed by the investigator.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2011 (estimated)
  2. Study start1 Mar 2011
  3. Primary completion31 Jul 2014
  4. Study completion31 Jul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01324947
Sponsor's protocol ID
CC-4047-MM-003/C
Other IDs
2010-023343-16
Status last verified
Nov 2019
First submitted
27 Mar 2011
Last updated
19 Nov 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 27173785

  • 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.

    PubMed 24007748

  • Morgan G, Palumbo A, Dhanasiri S, Lee D, Weisel K, Facon T, Delforge M, Oriol A, Zaki M, Yu X, Sternas L, Jacques C, Akehurst R, Offner F, Dimopoulos MA. Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone. Br J Haematol. 2015 Mar;168(6):820-3. doi: 10.1111/bjh.13227. Epub 2014 Nov 18.

    PubMed 25403264

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pomalidomide in people with Multiple Myeloma, run by Celgene at 91 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in France, Germany, United Kingdom, Australia, Italy and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01324947, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.

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