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

December 10, 2021 updated by: Celgene

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

682

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8036
        • Medical University of Graz
      • Innsbruck, Austria, 6020
        • Medizinische Universität Innsbruck
      • Vienna, Austria, A-1090
        • Medical University of Vienna
      • Vienna, Austria, 1160
        • Wilhelminenspital Vienna
  • Belgium
      • Brugge, Belgium, 8000
        • AZ St-Jan Brugge Oostende AV
      • Brussel, Belgium, 1090
        • VUB Vrije Universiteit Brussel
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Gent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liege, Belgium, 4000
        • Centre Hospitalier Universitaire de Liège
      • Yvoir, Belgium, 5530
        • CHU Mont -Godinne
  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital
      • Odense, Denmark, DK-5000
        • Odense University Hospital
      • Vejle, Denmark, 7100
        • Vejle Hospital
  • Estonia
      • Tartu, Estonia, 51014
        • Tartu University Hospital Clinic
  • Finland
      • Helsinki, Finland, FI-00290
        • Helsingin yliopistollinen keskussairaala
      • Turku, Finland, 20521
        • Turku University Hospital
  • France
      • Bayonne, France, 64109
        • Centre Hospitalier de la Côte Basque
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • La Tronche, France, 38700
        • Hôpital A. MICHALLON
      • Lille, France, 59037
        • CHRU Claude Huriez
      • Marseille cedex, France, 13273
        • Institut Paoli Calmette Hematologie
      • Nantes, France, 44093
        • CHU Hôtel Dieu
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Paris, France, 75475
        • Service Hemato-Immunologie Hopital St Louis
      • Pierre Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Reims cedex, France, 51092
        • CHU de Reims
      • Toulouse, France, 31059
        • Hematologie - CHU Purpan
      • Tours cedex, France, 37044
        • CHRU Hôpital Bretonneau
      • Vandoeuvre les Nancy, France, 54511
        • CHU Nancy Hematology
  • Germany
      • Berlin, Germany, 12200
        • Charite, Campus Benjamin Franklin Universitatsmedizin Berlin
      • Chemnitz, Germany, D-09113
        • Klinikum Chemnitz
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus
      • Dusseldorf, Germany, D-40225
        • Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie
      • Essen, Germany, 45122
        • Universitatsklinikum Essen-
      • Freiburg, Germany, D-79106
        • Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik
      • Hamburg, Germany, D-22763
        • Abt Haematologie - Onkologie / Allg. Krankenhaus Altona
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Jena, Germany, O7740
        • Universitätsklinikum Jena
      • Kiel, Germany, 24105
        • University of Schleswig Holstein
      • Köln, Germany, 50937
        • Klinikum der Universität zu Köln
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • Muenster, Germany, 48129
        • Universitatsklinik MuensterMedizinische Klinik A
      • München, Germany, 81675
        • TU München - Klinikum rechts der Isar
      • Tuebingen, Germany, 72076
        • UKT Universitaetsklinikum Tuebingen
      • Ulm, Germany, 89081
        • University Hospital of Ulm
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
  • Greece
      • Athens, Greece, 11528
        • University of Athens
  • Ireland
      • Dublin, Ireland, Dublin 7
        • Mater Misericordiae University Hospital
      • Galway, Ireland, ST46QG
        • University Hospital Galway
    • Cork
      • Wilton, Cork, Ireland
        • Cork University HospitalHaematology Consultant
  • Italy
      • Ancona, Italy, 60126
        • Ospedali Riuniti di Ancona
      • Bari, Italy, 70124
        • A.O. Policlinico - Università di Bari
      • Bologna, Italy, 40138
        • University of Bologna
      • Catania, Italy, 95124
        • Ospedale Ferrarotto
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda, Milano
      • Padova, Italy, 35128
        • Universita degli Studi di Padova
      • Palermo, Italy, 90146
        • Casa di Cura La Maddalena
      • Piacenza, Italy, 29100
        • Ospedale Civile di Piacenza
      • Pisa, Italy, 56126
        • Azienda Ospedaliero-Universitaria Pisana
      • Roma, Italy, 00168
        • Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I
      • Rome, Italy, 00144
        • Ospedale Sant'Eugenio
      • Torino, Italy, 10126
        • Azienda Ospedaliera San Giovanni Battista - Ospedale Molinette
      • Udine, Italy, 33100
        • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine
      • Vicenza, Italy, 36100
        • Ospedale San Bortolo
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Center VU Medisch Centrum
      • Den Haag, Netherlands, 2545 CH
        • Haga Hospital
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medical Center
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital, Rikshospitalet HF
      • Trondheim, Norway, N-7006
        • St. Olavs Hospital Trondheim
  • Poland
      • Gdansk, Poland, 80-211
        • Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii
      • Kraków, Poland, 31 501
        • Szpitala Uniwersyteckiego w. Krakowie
      • Warszawa, Poland, 02-776
        • Instytut Hematologii i Transfuzjologii w Warszawie
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra
      • Lisboa, Portugal, 1649-035
        • Hospital de Santa Maria
      • Lisboa, Portugal, 1099-023
        • Instituto Português de Oncologia de Lisboa
      • Porto, Portugal, 4099-001
        • Hospital Geral de Santo Antonio - Servico de Hematologia Clinica
  • Slovakia
      • Bratislava, Slovakia, 85107
        • University Hospital Bratislava - Hospital Ss Cyril and Methodius
  • Spain
      • Badalona (Barcelona), Spain, 8916
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • La Laguna (Tenerife), Spain, 38320
        • Hospital Universitario de Canarias
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28006
        • Hospital De La Princesa
      • Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Murcia, Spain, 30008
        • Hospital Morales Meseguer
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • San Sebastián (Guipuzcoa), Spain, 20014
        • Hospital de Donosti
      • Santiago De Compostela, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
      • Toledo, Spain, 45004
        • Hospital Virgen De La Salud
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
  • Sweden
      • Lund, Sweden, SE-22185
        • Universitetssjukhuset i Lund
      • Stockholm, Sweden, SE 17176
        • Karolinska University HospitalSolna
  • Switzerland
      • Bern, Switzerland, 3010
        • Universitätsspital Bern
      • Genèva, Switzerland, 1211
        • Hopitaux Universitaires de Geneve-HUG
      • Zurich, Switzerland, 8091
        • University Hospital Zurich
  • Turkey
      • Ankara, Turkey, 06590
        • Ankara University Medical Faculty Cebeci Hospital
      • Izmir, Turkey, 35100
        • Ege University Medical School
  • United Kingdom
      • Belfast Northern Ireland, United Kingdom, BT9 7AB
        • Belfast City Hospital Haematology Department
      • Canterbury/Kent, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals Trust
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Newcastle Hospital Foundation Trust
      • Sutton (Surrey), United Kingdom, SM2 5PT
        • Royal Marsden Hospital
      • Westbury-on-Trym/ Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pomalidomide plus Dexamethasone
Pomalidomide 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.
Drug: Pomalidomide
Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle
Drug: Dexamethasone
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response
Time Frame: Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
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
Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
Time to Response
Time Frame: Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
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.
Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
Kaplan Meier Estimate of Duration of Response
Time Frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
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.
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines
Time Frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
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.
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Kaplan Meier Estimate of Time to Progression
Time Frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
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).
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Kaplan Meier Estimate of Overall Survival (OS)
Time Frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
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.
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)
Time Frame: Cycles 1, 2, 3, 4, 5, 6
Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.
Cycles 1, 2, 3, 4, 5, 6
Pomalidomide Exposure - Apparent Volume of Distribution (V/F)
Time Frame: Cycles 1, 2, 3, 4, 5, 6
Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.
Cycles 1, 2, 3, 4, 5, 6
Cytogenetic Analysis
Time Frame: Study entry
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.
Study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Teresa Peluso, MBBS, DCPSA, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2012

Primary Completion (Actual)

December 11, 2019

Study Completion (Actual)

December 11, 2019

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (Estimate)

October 24, 2012

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-4047-MM-010
  • 2012-001888-78 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Pomalidomide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe