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A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma (Cassiopeia)

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab
Daratumumab
Sponsored by
Intergroupe Francophone du Myelome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Untreated Multiple Myeloma, daratumumab

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of previously untreated multiple myeloma (MM)
  • Have a confirmed diagnosis and eligible for high dose chemotherapy and autologous stem cell transplantation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1 or 2

Exclusion Criteria:

  • previous treatment for Multiple Myeloma
  • Primary amyloidosis, Plasma Cell Leukemia or Smoldering Multiple Myeloma
  • Prior or concurrent exposure to systemic therapy or SCT (Stem Cell Transplantation) for any plasma cell dyscrasia, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment, or received an investigational drug or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
  • history of malignancy (other than Multiple Myeloma) within 10 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
  • known chronic obstructive pulmonary disease (COPD) or moderate to severe asthma
  • any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study

Sites / Locations

  • BE-Antwerp-ZNA Stuivenberg
  • AZ St Jan Brugge Oostende AV
  • Institut Jules Bordet
  • UCL Saint-Luc
  • UZ Brussel
  • GHDC
  • UZ Gent
  • CH Jolimont
  • University Hospital Leuven
  • Domaine Universitaire du Sart Tilman
  • AZ Delta
  • AZ Turnhout
  • UCL Mont-Godinne
  • CHU Amiens Sud
  • CHRU-Hôpital du Bocage
  • Centre Hospitalier d'Argenteuil Victor Dupouy
  • Centre Hospitalier H.Duffaut
  • Centre hospitalier de la Côte Basque
  • Hôpital Jean Minjoz
  • Hôpital Avicenne
  • Polyclinique Bordeaux Nord Acquitaine
  • Hôpital de Fleyriat
  • CHRU Brest - Hôpital A. Morvan
  • CHU Caen - Côte de Nacre
  • Clinique du Parc
  • CH René Dubos
  • Hôpital Privé Sévigné
  • Centre Hospitalier William Morey
  • CH Chambéry
  • Hôpital d'Instruction des Armées Percy
  • CHU d'Estaing
  • Centre Hospitalier Sud Francilien
  • CHU Henri Mondor
  • CHRU Dijon - Hôpital des Enfants
  • Centre Hospitalier Général
  • CHRU Hôpital A. Michallon
  • CHD Vendée
  • CHV André Mignot - Université de Versailles
  • CH de Chartres - Hôpital Louis Pasteur
  • Centre Hospitalier
  • Clinique Victor Hugo
  • CHRU Hôpital Claude Huriez
  • GH de l'Institut Catholique Saint Vincent
  • Centre Hospitalier Universitaire (CHU) de Limoges
  • Hôpital du Scorff
  • Centre Léon Bérard
  • Institut Paoli Calmettes
  • CH Meaux
  • Hôpital de Mercy (CHR Metz-Thionville)
  • Hopital Saint Eloi - CHU Montpellier
  • Hôpital E. Muller
  • CHRU Hôtel Dieu
  • Centre Catherine de Sienne
  • Clinique de l'Archet
  • CHU Carémeau
  • CH La Source
  • Hôpital Saint Louis
  • CHU Hôpital Saint Antoine
  • Hôpital Cochin
  • Hôpital Necker
  • Institut Curie
  • La Pitié
  • Centre Hospitalier de Perigueux
  • CH Saint Jean
  • CHRU - Hôpital du Haut Lévêque - Centre François Magendie
  • Centre Hospitalier Lyon Sud
  • CHU Poitiers - Pôle régional de Cancérologie
  • Ch Annecy Genevois
  • Hôpital Robert Debré
  • CHRU Hôpital de Pontchaillou
  • Centre Henri Becquerel
  • Institut de Cancérologie Lucien Neuwirth
  • Centre Hospitalier
  • Centre Hospitalier Yves Le Foll
  • CHU Strasbourg
  • Strasbourg Oncologie Médicale
  • Pôle IUCT Oncopole CHU
  • CHRU Hôpital Bretonneau
  • CHRU Hôpitaux de Brabois
  • CHBA
  • MC Alkmaar
  • Meander MC
  • AMC
  • OLVG
  • Vumc
  • Ziekenhuis Rijnstate
  • Amphia Hospital Breda
  • RdGG
  • Haga zkh
  • Deventer zkh
  • Albert Schweitzer zkh
  • Maxima MC
  • Medisch Spectrum Twente
  • UMCG
  • Atrium MC/Zuyderland MC
  • Tergooiziekenhuizen, location Hilversum
  • Spaarne Gasthuis
  • MC Leeuwarden
  • LUMC
  • MUMC
  • Antonius zkh
  • Radboudumc
  • Erasmus MC
  • Maasstad Ziekenhuis
  • Elisabeth zkh
  • UMCU
  • Isala Klinieken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

No Intervention

Experimental

Arm Label

Arm A Part 1

Arm B Part 1

Arm A Part 2

Arm B Part 2

Arm Description

Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)

Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab

Observation

daratumumab

Outcomes

Primary Outcome Measures

stringent complete response (sCR) after consolidation therapy
sCR is defined by achieving CR (complete response) in addition to having a normal serum FLC (Free Light Chain) ratio and absence of clonal cells in bone marrow
Progression free survival after maintenance therapy
Time from the date of second randomization to either progressive disease (PD) or death

Secondary Outcome Measures

PFS (Progression-Free Survival) (from first randomization)
time from the initial randomization to either confirmed progressive disease (PD) or death
Time to Progression (TTP)
Time from the initial randomization to confirmed progressive disease (PD) or death due to progressive disease
proportion of Post ASCT (Autologous Stem Cell Transplantation) / consolidation CR rate
Proportion of participants who have achieved CR or sCR by the end of consolidation treatment
proportion of Post ASCT/consolidation MRD (Minimal Residual Disease) negativation
proportion of participants who have achieved MRD (minimal residual disease) negative status by the end of consolidation
proportion of Post induction sCR
proportion of participants who have achieved sCR (stringent complete response) prior to high-dose therapy/ASCT (autologous stem cell transplantation)
PFS 2 (from first randomization)
time from initial randomization to subsequent progression on next-line of therapy after disease progression on study treatment
OS (overall survival) (from first randomization)
time from initial randomization to death

Full Information

First Posted
June 24, 2015
Last Updated
December 3, 2020
Sponsor
Intergroupe Francophone du Myelome
Collaborators
HOVON - Dutch Haemato-Oncology Association, Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02541383
Brief Title
A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
Acronym
Cassiopeia
Official Title
Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (Actual)
Primary Completion Date
August 27, 2020 (Actual)
Study Completion Date
June 19, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intergroupe Francophone du Myelome
Collaborators
HOVON - Dutch Haemato-Oncology Association, Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.
Detailed Description
This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 2-arm (2 treatment groups), multicenter study of daratumumab in participants diagnosed with previously untreated Multiple Myeloma who are eligible for high dose chemotherapy and autologous stem cell transplantation (transplantation of own bone marrow). Participants will be randomized (assigned by chance) to one of 2 treatment groups to either receive daratumumab plus bortezomib, thalidomide and dexamethasone or bortezomib, thalidomide and dexamethasone for induction (before transplantation) and consolidation (after transplantation) treatment. All responders will then be re-randomized (assigned by chance) to one of 2 treatment groups to receive maintenance treatment with daratumumab only or observation (no treatment). The study will include a 28-Day Screening Phase, a Treatment Phase of 6 treatment cycles (each cycle is 4 weeks in duration for total period of 30 weeks), and a Follow up Phase of 2 years. The total duration for each participant in the study will be approximately 138 weeks. The end of the study will occur approximately 5 years after the last participant is randomized in the second phase of the study. Disease assessments will be performed every 4 weeks in the first phase of the study and then every 8 weeks in the second phase of the study. Safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Untreated Multiple Myeloma, daratumumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1085 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A Part 1
Arm Type
Other
Arm Description
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Arm Title
Arm B Part 1
Arm Type
Experimental
Arm Description
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab
Arm Title
Arm A Part 2
Arm Type
No Intervention
Arm Description
Observation
Arm Title
Arm B Part 2
Arm Type
Experimental
Arm Description
daratumumab
Intervention Type
Drug
Intervention Name(s)
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Other Intervention Name(s)
Arm A Part 1
Intervention Description
Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation
Intervention Type
Drug
Intervention Name(s)
Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab
Other Intervention Name(s)
Arm B Part 1
Intervention Description
Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
Arm B Part 2
Intervention Description
Daratumumab 16mg/kg every 8 weeks for 2 years
Primary Outcome Measure Information:
Title
stringent complete response (sCR) after consolidation therapy
Description
sCR is defined by achieving CR (complete response) in addition to having a normal serum FLC (Free Light Chain) ratio and absence of clonal cells in bone marrow
Time Frame
Up to 9 months
Title
Progression free survival after maintenance therapy
Description
Time from the date of second randomization to either progressive disease (PD) or death
Time Frame
up to 60 months
Secondary Outcome Measure Information:
Title
PFS (Progression-Free Survival) (from first randomization)
Description
time from the initial randomization to either confirmed progressive disease (PD) or death
Time Frame
Up to 60 months
Title
Time to Progression (TTP)
Description
Time from the initial randomization to confirmed progressive disease (PD) or death due to progressive disease
Time Frame
Up to 60 months
Title
proportion of Post ASCT (Autologous Stem Cell Transplantation) / consolidation CR rate
Description
Proportion of participants who have achieved CR or sCR by the end of consolidation treatment
Time Frame
Up to 9 months
Title
proportion of Post ASCT/consolidation MRD (Minimal Residual Disease) negativation
Description
proportion of participants who have achieved MRD (minimal residual disease) negative status by the end of consolidation
Time Frame
Up to 9 months
Title
proportion of Post induction sCR
Description
proportion of participants who have achieved sCR (stringent complete response) prior to high-dose therapy/ASCT (autologous stem cell transplantation)
Time Frame
Up to 4 months
Title
PFS 2 (from first randomization)
Description
time from initial randomization to subsequent progression on next-line of therapy after disease progression on study treatment
Time Frame
Up to 60 months
Title
OS (overall survival) (from first randomization)
Description
time from initial randomization to death
Time Frame
Up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of previously untreated multiple myeloma (MM) Have a confirmed diagnosis and eligible for high dose chemotherapy and autologous stem cell transplantation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1 or 2 Exclusion Criteria: previous treatment for Multiple Myeloma Primary amyloidosis, Plasma Cell Leukemia or Smoldering Multiple Myeloma Prior or concurrent exposure to systemic therapy or SCT (Stem Cell Transplantation) for any plasma cell dyscrasia, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment, or received an investigational drug or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1 history of malignancy (other than Multiple Myeloma) within 10 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix known chronic obstructive pulmonary disease (COPD) or moderate to severe asthma any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Moreau, Pr
Organizational Affiliation
CHU Nantes, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
BE-Antwerp-ZNA Stuivenberg
City
Antwerp
Country
Belgium
Facility Name
AZ St Jan Brugge Oostende AV
City
Brugge
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
Country
Belgium
Facility Name
UCL Saint-Luc
City
Bruxelles
Country
Belgium
Facility Name
UZ Brussel
City
Bruxelles
Country
Belgium
Facility Name
GHDC
City
Charleroi
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
CH Jolimont
City
La Louviere
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
Country
Belgium
Facility Name
Domaine Universitaire du Sart Tilman
City
Liege
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Facility Name
AZ Turnhout
City
Turnhout
Country
Belgium
Facility Name
UCL Mont-Godinne
City
Yvoir
Country
Belgium
Facility Name
CHU Amiens Sud
City
AMIENS Cedex 1
Country
France
Facility Name
CHRU-Hôpital du Bocage
City
ANGERS Cedex 1
Country
France
Facility Name
Centre Hospitalier d'Argenteuil Victor Dupouy
City
Argenteuil
Country
France
Facility Name
Centre Hospitalier H.Duffaut
City
AVIGNON Cedex 9
Country
France
Facility Name
Centre hospitalier de la Côte Basque
City
Bayonne
Country
France
Facility Name
Hôpital Jean Minjoz
City
BESANCON Cedex
Country
France
Facility Name
Hôpital Avicenne
City
BOBIGNY Cedex
Country
France
Facility Name
Polyclinique Bordeaux Nord Acquitaine
City
Bordeaux
Country
France
Facility Name
Hôpital de Fleyriat
City
BOURG EN BRESSE Cedex
Country
France
Facility Name
CHRU Brest - Hôpital A. Morvan
City
BREST Cedex
Country
France
Facility Name
CHU Caen - Côte de Nacre
City
CAEN Cedex
Country
France
Facility Name
Clinique du Parc
City
Castelnau-le-lez
Country
France
Facility Name
CH René Dubos
City
Cergy-pontoise
Country
France
Facility Name
Hôpital Privé Sévigné
City
Cesson-Sévigné
Country
France
Facility Name
Centre Hospitalier William Morey
City
Chalon-sur-Saône
ZIP/Postal Code
71100
Country
France
Facility Name
CH Chambéry
City
Chambery
Country
France
Facility Name
Hôpital d'Instruction des Armées Percy
City
CLAMART Cedex
Country
France
Facility Name
CHU d'Estaing
City
Clermont-ferrand
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
CORBEIL-ESSONNES Cedex
Country
France
Facility Name
CHU Henri Mondor
City
Creteil
Country
France
Facility Name
CHRU Dijon - Hôpital des Enfants
City
Dijon
Country
France
Facility Name
Centre Hospitalier Général
City
Dunkerque
Country
France
Facility Name
CHRU Hôpital A. Michallon
City
GRENOBLE Cedex 9
Country
France
Facility Name
CHD Vendée
City
LA ROCHE SUR YON Cedex 9
Country
France
Facility Name
CHV André Mignot - Université de Versailles
City
Le Chesnay
Country
France
Facility Name
CH de Chartres - Hôpital Louis Pasteur
City
Le Coudray
Country
France
Facility Name
Centre Hospitalier
City
LE MANS Cedex
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
Country
France
Facility Name
CHRU Hôpital Claude Huriez
City
LILLE Cedex
Country
France
Facility Name
GH de l'Institut Catholique Saint Vincent
City
Lille
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) de Limoges
City
Limoges
Country
France
Facility Name
Hôpital du Scorff
City
Lorient
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Institut Paoli Calmettes
City
MARSEILLE Cedex
Country
France
Facility Name
CH Meaux
City
Meaux
Country
France
Facility Name
Hôpital de Mercy (CHR Metz-Thionville)
City
METZ Cedex 1
Country
France
Facility Name
Hopital Saint Eloi - CHU Montpellier
City
MONTPELLIER Cedex
Country
France
Facility Name
Hôpital E. Muller
City
Mulhouse
Country
France
Facility Name
CHRU Hôtel Dieu
City
Nantes Cedex 1
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44202
Country
France
Facility Name
Clinique de l'Archet
City
NICE Cedex 3
Country
France
Facility Name
CHU Carémeau
City
NIMES Cedex 9
Country
France
Facility Name
CH La Source
City
Orleans Cedex 2
Country
France
Facility Name
Hôpital Saint Louis
City
PARIS Cedex 10
Country
France
Facility Name
CHU Hôpital Saint Antoine
City
PARIS Cedex 12
Country
France
Facility Name
Hôpital Cochin
City
Paris
Country
France
Facility Name
Hôpital Necker
City
Paris
Country
France
Facility Name
Institut Curie
City
Paris
Country
France
Facility Name
La Pitié
City
Paris
Country
France
Facility Name
Centre Hospitalier de Perigueux
City
Perigueux
Country
France
Facility Name
CH Saint Jean
City
Perpignan
Country
France
Facility Name
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
City
Pessac
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
PIERRE-BENITE Cedex
Country
France
Facility Name
CHU Poitiers - Pôle régional de Cancérologie
City
Poitiers
Country
France
Facility Name
Ch Annecy Genevois
City
PRINGY Cedex
Country
France
Facility Name
Hôpital Robert Debré
City
REIMS Cedex
Country
France
Facility Name
CHRU Hôpital de Pontchaillou
City
RENNES Cedex 9
Country
France
Facility Name
Centre Henri Becquerel
City
ROUEN Cedex 1
Country
France
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
Saint Priest-en-jarez
Country
France
Facility Name
Centre Hospitalier
City
SAINT QUENTIN Cedex
Country
France
Facility Name
Centre Hospitalier Yves Le Foll
City
Saint-brieuc
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Facility Name
Strasbourg Oncologie Médicale
City
Strasbourg
Country
France
Facility Name
Pôle IUCT Oncopole CHU
City
TOULOUSE Cedex 9
Country
France
Facility Name
CHRU Hôpital Bretonneau
City
TOURS Cedex
Country
France
Facility Name
CHRU Hôpitaux de Brabois
City
VANDOEUVRE LES NANCY Cedex
Country
France
Facility Name
CHBA
City
VANNES Cedex
Country
France
Facility Name
MC Alkmaar
City
Alkmaar
Country
Netherlands
Facility Name
Meander MC
City
Amersfoort
Country
Netherlands
Facility Name
AMC
City
Amsterdam
Country
Netherlands
Facility Name
OLVG
City
Amsterdam
Country
Netherlands
Facility Name
Vumc
City
Amsterdam
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
Amphia Hospital Breda
City
Breda
Country
Netherlands
Facility Name
RdGG
City
Delft
Country
Netherlands
Facility Name
Haga zkh
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Deventer zkh
City
Deventer
Country
Netherlands
Facility Name
Albert Schweitzer zkh
City
Dordrecht
Country
Netherlands
Facility Name
Maxima MC
City
Eindhoven
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
UMCG
City
Groningen
Country
Netherlands
Facility Name
Atrium MC/Zuyderland MC
City
Heerlen
Country
Netherlands
Facility Name
Tergooiziekenhuizen, location Hilversum
City
Hilversum
ZIP/Postal Code
1201 DA
Country
Netherlands
Facility Name
Spaarne Gasthuis
City
Hoofddorp
Country
Netherlands
Facility Name
MC Leeuwarden
City
Leeuwarden
Country
Netherlands
Facility Name
LUMC
City
Leiden
Country
Netherlands
Facility Name
MUMC
City
Maastricht
Country
Netherlands
Facility Name
Antonius zkh
City
Nieuwegein
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
Elisabeth zkh
City
Tilburg
Country
Netherlands
Facility Name
UMCU
City
Utrecht
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31171419
Citation
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Links:
URL
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-transplant-eligible-multiple-myeloma
Description
FDA approval
URL
https://ir.genmab.com/news-releases/news-release-details/genmab-announces-ifm-hovon-and-janssen-achieve-positive-topline/
Description
positive study part II results

Learn more about this trial

A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

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