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Multiple MyelomaPhase 3STRATUSNCT01712789

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

A Phase 3 study testing Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 112 sites in 20 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 primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. 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 and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
682 participants
Where
112 sitesin 20 countries
Study dates
6 Nov 2012to 11 Dec 2019
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

  • Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent.
  • Patients must have documented diagnosis of Multiple Myeloma and have measurable disease.
  • Patients must have undergone prior treatment with ≥ 2 treatments lines, of anti-myeloma therapy.
  • Patients must have either refractory or relapsed and refractory disease.
  • Patients must have received at least 2 consecutive cycles of prior treatment that include lenalidomide and bortezomib, either alone or in combination regimens.
  • Patients must have received adequate alkylator therapy

Who cannot join

  • Prior history of malignancies, other than Multiple Myeloma.
  • Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide or dexamethasone.
  • Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant.
  • Patients who are planning for or who are eligible for stem cell transplant.
  • Patients who received major surgery and any anti-myeloma drug therapy within the last 14 days of starting study treatment.
  • Patients with a current disease that can interfere with protocol procedures or study treatment.
  • Patients unable or unwilling to undergo antithrombotic prophylactic treatment.
  • Pregnant or breastfeeding females.

Trial locations and contacts

112 sites in 20 countries.

112 sites in 20 countries

Germany17 sites

  • Charite, Campus Benjamin Franklin Universitatsmedizin Berlin

    Berlin, 12200

  • Klinikum Chemnitz

    Chemnitz, D-09113

  • Klinikum der Universitat zu Koln

    Cologne, 50937

  • Universitatsklinikum Carl Gustav Carus

    Dresden, 01307

  • Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie

    Düsseldorf, D-40225

  • Universitatsklinikum Essen-

    Essen, 45122

  • Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik

    Freiburg im Breisgau, D-79106

  • Abt Haematologie - Onkologie / Allg. Krankenhaus Altona

    Hamburg, D-22763

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

  • Universitatsklinikum Jena

    Jena, O7740

  • University of Schleswig Holstein

    Kiel, 24105

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • TU München - Klinikum rechts der Isar

    München, 81675

  • Universitatsklinik MuensterMedizinische Klinik A

    Münster, 48129

  • UKT Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • University Hospital of Ulm

    Ulm, 89081

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Italy15 sites

  • Ospedali Riuniti di Ancona

    Ancona, 60126

  • A.O. Policlinico - Università di Bari

    Bari, 70124

  • University of Bologna

    Bologna, 40138

  • Ospedale Ferrarotto

    Catania, 95124

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • ASST Grande Ospedale Metropolitano Niguarda, Milano

    Milan, 20162

  • Universita degli Studi di Padova

    Padova, 35128

  • Casa di Cura La Maddalena

    Palermo, 90146

  • Ospedale Civile di Piacenza

    Piacenza, 29100

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

  • Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I

    Roma, 00168

  • Ospedale Sant'Eugenio

    Rome, 00144

  • Azienda Ospedaliera San Giovanni Battista - Ospedale Molinette

    Torino, 10126

  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

    Udine, 33100

  • Ospedale San Bortolo

    Vicenza, 36100

Other trials in Italy

Spain15 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona (Barcelona), 8916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitario de Canarias

    La Laguna (Tenerife), 38320

  • Hospital de La Princesa

    Madrid, 28006

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen De La Victoria

    Málaga, 29010

  • Hospital Morales Meseguer

    Murcia, 30008

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital de Donosti

    San Sebastián (Guipuzcoa), 20014

  • Hospital Clinico Universitario De Santiago De Compostela

    Santiago de Compostela, 15706

  • Hospital Virgen de la Salud

    Toledo, 45004

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

France13 sites

  • Centre Hospitalier de la cote basque

    Bayonne, 64109

  • Hopital Henri Mondor

    Créteil, 94010

  • Hopital A. Michallon

    La Tronche, 38700

  • CHRU Claude Huriez

    Lille, 59037

  • Institut Paoli Calmette Hematologie

    Marseille, 13273

  • CHU Hotel Dieu

    Nantes, 44093

  • Hopital Saint Antoine

    Paris, 75012

  • Service Hemato-Immunologie Hopital St Louis

    Paris, 75475

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Reims

    Reims, 51092

  • Hematologie - CHU Purpan

    Toulouse, 31059

  • CHRU Hopital Bretonneau

    Tours, 37044

  • CHU Nancy Hematology

    Vandœuvre-lès-Nancy, 54511

Other trials in France

United Kingdom9 sites

  • Belfast City Hospital Haematology Department

    Belfast Northern Ireland, BT9 7AB

  • Kent and Canterbury Hospital

    Canterbury/Kent, CT1 3NG

  • Leeds Teaching Hospitals Trust

    Leeds, LS9 7TF

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

  • Newcastle Hospital Foundation Trust

    Newcastle upon Tyne, NE7 7DN

  • Royal Marsden Hospital

    Sutton (Surrey), SM2 5PT

  • Southmead Hospital

    Westbury-on-Trym/ Bristol, BS10 5NB

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Belgium7 sites

  • AZ St-Jan Brugge Oostende AV

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • VUB Vrije Universiteit Brussel

    Brussels, 1090

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege

    Liège, 4000

  • CHU Mont -Godinne

    Yvoir, 5530

Other trials in Belgium

Netherlands5 sites

  • VU University Medical Center VU Medisch Centrum

    Amsterdam, 1081 HV

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Erasmus Medical Center

    Rotterdam, 3015 CE

  • Haga Hospital

    The Hague, 2545 CH

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Austria4 sites

  • Medical University of Graz

    Graz, A-8036

  • Medizinische Universitat Innsbruck

    Innsbruck, 6020

  • Wilhelminenspital Vienna

    Vienna, 1160

  • Medical University of Vienna

    Vienna, A-1090

Other trials in Austria

Portugal4 sites

  • Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra

    Coimbra, 3000-075

  • Instituto Portugues de Oncologia de Lisboa

    Lisbon, 1099-023

  • Hospital de Santa Maria

    Lisbon, 1649-035

  • Hospital Geral de Santo António - Serviço de Hematologia Clínica

    Porto, 4099-001

Other trials in Portugal

Denmark3 sites

  • Aarhus University Hospital

    Aarhus, 8000

  • Odense University Hospital

    Odense, DK-5000

  • Vejle Hospital

    Vejle, 7100

Other trials in Denmark

Ireland3 sites

  • Mater Misericordiae University Hospital

    Dublin, Dublin 7

  • University Hospital Galway

    Galway, ST46QG

  • Cork University HospitalHaematology Consultant

    Wilton, Cork

Other trials in Ireland

Poland3 sites

  • Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii

    Gdansk, 80-211

  • Szpitala Uniwersyteckiego w. Krakowie

    Krakow, 31 501

  • Instytut Hematologii i Transfuzjologii w Warszawie

    Warsaw, 02-776

Other trials in Poland

Switzerland3 sites

  • Universitatsspital Bern

    Bern, 3010

  • Hopitaux Universitaires de Geneve-HUG

    Genèva, 1211

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

Finland2 sites

  • Helsingin yliopistollinen keskussairaala

    Helsinki, FI-00290

  • Turku University Hospital

    Turku, 20521

Other trials in Finland

Norway2 sites

  • Oslo University Hospital, Rikshospitalet HF

    Oslo, 0424

  • St. Olavs Hospital Trondheim

    Trondheim, N-7006

Other trials in Norway

Sweden2 sites

  • Universitetssjukhuset i Lund

    Lund, SE-22185

  • Karolinska University HospitalSolna

    Stockholm, SE 17176

Other trials in Sweden

Turkey (Türkiye)2 sites

  • Ankara University Medical Faculty Cebeci Hospital

    Ankara, 06590

  • Ege University Medical School

    Izmir, 35100

Other trials in Turkey (Türkiye)

Estonia1 site

  • Tartu University Hospital Clinic

    Tartu, 51014

Other trials in Estonia

Greece1 site

  • University of Athens

    Athens, 11528

Other trials in Greece

Slovakia1 site

  • University Hospital Bratislava - Hospital Ss Cyril and Methodius

    Bratislava, 85107

Other trials in Slovakia

About this study

Official title: A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.

The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years.

Read more

In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses.

The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.

Keywords
Multiple Myeloma, Relapsed Multiple Myeloma, Relapsed and refractory Multiple Myeloma, Pomalidomide, Dexamethasone
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

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

  • PomalidomideDrug

    Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle

  • DexamethasoneDrug

    Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.

Study groups in NCT01712789
Study groupRoleWhat they receive
Pomalidomide plus DexamethasoneExperimentalPomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.
Receives: Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

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

  1. Number of Participants With Treatment Emergent Adverse Events (TEAE)

    An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.

    A SAE = AE occurring at any dose that:

    • Results in death;
    • Is life-threatening
    • Requires inpatient hospitalization or prolongation of existing hospitalization
    • Results in persistent or significant disability/incapacity
    • Is a congenital anomaly/birth defect

    Measured: From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.

Secondary outcomes (9)

  1. Overall Response

    Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions

    Measured: Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks

  2. Time to Response

    Time to response was defined as the time from treatment enrollment to the first documentation of response (sCR, CR, VGPR or PR) based on IMWG criteria.

    Measured: Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks

  3. Kaplan Meier Estimate of Duration of Response

    Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment.

    Measured: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months

  4. Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines

    Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted.

    Measured: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months

  5. Kaplan Meier Estimate of Time to Progression

    Time to progression was calculated as the time from study enrollment until first recorded disease progression as determined by the site investigator based on the IMWG criteria, or until death due to progression. Participants not experiencing a documented progression were censored at the time of their last tumor assessment (or at the time of trial enrollment if no assessment was conducted).

    Measured: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months

  6. Kaplan Meier Estimate of Overall Survival (OS)

    Overall survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until death due to any cause. Participants who did not have death data at the time of study end/analysis were censored at the time they were last known to be alive.

    Measured: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months

  7. Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)

    Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.

    Measured: Cycles 1, 2, 3, 4, 5, 6

  8. Pomalidomide Exposure - Apparent Volume of Distribution (V/F)

    Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.

    Measured: Cycles 1, 2, 3, 4, 5, 6

  9. Cytogenetic Analysis

    Cytogenetic analysis was to be performed using fluorescence in situ hybridization (FISH) methodology at a local laboratory, to evaluate the relationship between cytogenetic profiles and the combination of POM and LD-DEX in terms of response and outcome.

    Measured: Study entry

Timeline

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

  1. First posted24 Oct 2012 (estimated)
  2. Study start6 Nov 2012
  3. Primary completion11 Dec 2019
  4. Study completion11 Dec 2019

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
682 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01712789
Sponsor's protocol ID
CC-4047-MM-010
Other IDs
2012-001888-78
Acronym
STRATUS
Status last verified
Dec 2021
First submitted
22 Oct 2012
Last updated
10 Jan 2022
Data monitoring committee
Yes

Publications

  • Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, Weisel KC, Oriol A, Hansson M, Vacca A, Blanchard MJ, Goldschmidt H, Doyen C, Kaiser M, Petrini M, Anttila P, Cafro AM, Raymakers R, San-Miguel J, de Arriba F, Knop S, Rollig C, Ocio EM, Morgan G, Miller N, Simcock M, Peluso T, Herring J, Sternas L, Zaki MH, Moreau P. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma. Blood. 2016 Jul 28;128(4):497-503. doi: 10.1182/blood-2016-02-700872. Epub 2016 May 25.

    PubMed 27226434

  • Moreau P, Dimopoulos MA, Richardson PG, Siegel DS, Cavo M, Corradini P, Weisel K, Delforge M, O'Gorman P, Song K, Chen C, Bahlis N, Oriol A, Hansson M, Kaiser M, Anttila P, Raymakers R, Joao C, Cook G, Sternas L, Biyukov T, Slaughter A, Hong K, Herring J, Yu X, Zaki M, San-Miguel J. Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.

    PubMed 28504846

  • Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2.

    PubMed 30068263

  • 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.

    PubMed 27267105

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 112 sites in 20 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 6 inclusion and 8 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 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in Germany, Italy, Spain, France, United Kingdom and 15 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 10 Jan 2022). 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?

Number of Participants With Treatment Emergent Adverse Events (TEAE) (time frame: From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 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 NCT01712789, which also lists 4 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 10 Jan 2022.

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