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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pomalidomide
Dexamethasone
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Relapsed Multiple Myeloma, Relapsed and refractory Multiple Myeloma, Pomalidomide, Dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of Graz
  • Medizinische Universitat Innsbruck
  • Wilhelminenspital Vienna
  • Medical University of Vienna
  • AZ St-Jan Brugge Oostende AV
  • Institut Jules Bordet
  • VUB Vrije Universiteit Brussel
  • UZ Gent
  • UZ Leuven
  • Centre Hospitalier Universitaire de Liege
  • CHU Mont -Godinne
  • Aarhus University Hospital
  • Odense University Hospital
  • Vejle Hospital
  • Tartu University Hospital Clinic
  • Helsingin yliopistollinen keskussairaala
  • Turku University Hospital
  • Centre Hospitalier de la cote basque
  • Hopital Henri Mondor
  • Hopital A. Michallon
  • CHRU Claude Huriez
  • Institut Paoli Calmette Hematologie
  • CHU Hotel Dieu
  • Hopital Saint Antoine
  • Service Hemato-Immunologie Hopital St Louis
  • Centre Hospitalier Lyon Sud
  • CHU de Reims
  • Hematologie - CHU Purpan
  • CHRU Hopital Bretonneau
  • CHU Nancy Hematology
  • Charite, Campus Benjamin Franklin Universitatsmedizin Berlin
  • Klinikum Chemnitz
  • Universitatsklinikum Carl Gustav Carus
  • Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie
  • Universitatsklinikum Essen-
  • Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik
  • Abt Haematologie - Onkologie / Allg. Krankenhaus Altona
  • Universitatsklinikum Heidelberg
  • Universitatsklinikum Jena
  • University of Schleswig Holstein
  • Klinikum der Universitat zu Koln
  • Universitatsklinikum Leipzig
  • Universitatsklinik MuensterMedizinische Klinik A
  • TU München - Klinikum rechts der Isar
  • UKT Universitaetsklinikum Tuebingen
  • University Hospital of Ulm
  • Universitatsklinikum Wurzburg
  • University of Athens
  • Cork University HospitalHaematology Consultant
  • Mater Misericordiae University Hospital
  • University Hospital Galway
  • Ospedali Riuniti di Ancona
  • A.O. Policlinico - Università di Bari
  • University of Bologna
  • Ospedale Ferrarotto
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • ASST Grande Ospedale Metropolitano Niguarda, Milano
  • Universita degli Studi di Padova
  • Casa di Cura La Maddalena
  • Ospedale Civile di Piacenza
  • Azienda Ospedaliero-Universitaria Pisana
  • Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I
  • Ospedale Sant'Eugenio
  • Azienda Ospedaliera San Giovanni Battista - Ospedale Molinette
  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine
  • Ospedale San Bortolo
  • VU University Medical Center VU Medisch Centrum
  • Haga Hospital
  • Universitair Medisch Centrum Groningen
  • Erasmus Medical Center
  • University Medical Center Utrecht
  • Oslo University Hospital, Rikshospitalet HF
  • St. Olavs Hospital Trondheim
  • Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii
  • Szpitala Uniwersyteckiego w. Krakowie
  • Instytut Hematologii i Transfuzjologii w Warszawie
  • Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra
  • Instituto Portugues de Oncologia de Lisboa
  • Hospital de Santa Maria
  • Hospital Geral de Santo António - Serviço de Hematologia Clínica
  • University Hospital Bratislava - Hospital Ss Cyril and Methodius
  • Hospital Universitari Germans Trias i Pujol
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario de Canarias
  • Hospital de La Princesa
  • Hospital Ramon y Cajal
  • Hospital Clinico San Carlos
  • Hospital 12 de Octubre
  • Hospital Universitario Virgen De La Victoria
  • Hospital Morales Meseguer
  • Clinica Universidad de Navarra
  • Hospital Universitario de Salamanca
  • Hospital de Donosti
  • Hospital Clinico Universitario De Santiago De Compostela
  • Hospital Virgen de la Salud
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Universitetssjukhuset i Lund
  • Karolinska University HospitalSolna
  • Universitatsspital Bern
  • Hopitaux Universitaires de Geneve-HUG
  • University Hospital Zurich
  • Ankara University Medical Faculty Cebeci Hospital
  • Ege University Medical School
  • Belfast City Hospital Haematology Department
  • Kent and Canterbury Hospital
  • Leeds Teaching Hospitals Trust
  • Royal Liverpool University Hospital
  • Christie Hospital NHS Foundation Trust
  • Newcastle Hospital Foundation Trust
  • Royal Marsden Hospital
  • Southmead Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pomalidomide plus Dexamethasone

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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.
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).
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.
Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)
Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.
Pomalidomide Exposure - Apparent Volume of Distribution (V/F)
Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.
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.

Full Information

First Posted
October 22, 2012
Last Updated
December 10, 2021
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT01712789
Brief Title
Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
Acronym
STRATUS
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2012 (Actual)
Primary Completion Date
December 11, 2019 (Actual)
Study Completion Date
December 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Relapsed Multiple Myeloma, Relapsed and refractory Multiple Myeloma, Pomalidomide, Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
682 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pomalidomide plus Dexamethasone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Description
Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Description
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
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.
Secondary Outcome Measure Information:
Title
Overall Response
Description
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
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
Title
Time to Response
Description
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.
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
Title
Kaplan Meier Estimate of Duration of Response
Description
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.
Time Frame
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Title
Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines
Description
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.
Time Frame
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Title
Kaplan Meier Estimate of Time to Progression
Description
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).
Time Frame
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Title
Kaplan Meier Estimate of Overall Survival (OS)
Description
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.
Time Frame
From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
Title
Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)
Description
Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.
Time Frame
Cycles 1, 2, 3, 4, 5, 6
Title
Pomalidomide Exposure - Apparent Volume of Distribution (V/F)
Description
Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.
Time Frame
Cycles 1, 2, 3, 4, 5, 6
Title
Cytogenetic Analysis
Description
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.
Time Frame
Study entry

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
27226434
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
30068263
Citation
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.
Results Reference
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PubMed Identifier
27267105
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.
Results Reference
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Learn more about this trial

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

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