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

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ClinicalTrials.gov Identifier: NCT02541383
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : June 2, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

June 24, 2015
September 4, 2015
June 2, 2016
September 2015
August 2022   (Final data collection date for primary outcome measure)
  • stringent complete response (sCR) after consolidation therapy [ Time Frame: Up to 9 months ]
    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 Frame: up to 60 months ]
    Time from the date of second randomization to either progressive disease (PD) or death
Same as current
Complete list of historical versions of study NCT02541383 on ClinicalTrials.gov Archive Site
  • PFS (Progression-Free Survival) (from first randomization) [ Time Frame: Up to 60 months ]
    time from the initial randomization to either confirmed progressive disease (PD) or death
  • Time to Progression (TTP) [ Time Frame: Up to 60 months ]
    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 [ Time Frame: Up to 9 months ]
    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 [ Time Frame: Up to 9 months ]
    proportion of participants who have achieved MRD (minimal residual disease) negative status by the end of consolidation
  • proportion of Post induction sCR [ Time Frame: Up to 4 months ]
    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 Frame: Up to 60 months ]
    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 Frame: Up to 60 months ]
    time from initial randomization to death
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
    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
    Other Name: Arm A Part 1
  • Drug: Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab
    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
    Other Name: Arm B Part 1
  • Drug: Daratumumab
    Daratumumab 16mg/kg every 8 weeks for 2 years
    Other Name: Arm B Part 2
  • Arm A Part 1
    Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
    Intervention: Drug: Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
  • Experimental: Arm B Part 1
    Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab
    Intervention: Drug: Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab
  • No Intervention: Arm A Part 2
    Observation
  • Experimental: Arm B Part 2
    daratumumab
    Intervention: Drug: Daratumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1080
August 2024
August 2022   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: Claire Mathiot, Dr 0033157276829 ifmsecretgene@outlook.fr
Belgium,   France,   Luxembourg,   Netherlands
 
 
NCT02541383
IFM 2015-01
HO131 ( Other Identifier: HOVON )
54767414MMY3006 ( Other Identifier: J&J )
2014-004781-15 ( EudraCT Number )
Yes
Not Provided
Not Provided
Intergroupe Francophone du Myelome
Intergroupe Francophone du Myelome
  • HOVON - Dutch Haemato-Oncology Association
  • Janssen Research & Development, LLC
Principal Investigator: Philippe Moreau, Pr CHU Nantes, France
Intergroupe Francophone du Myelome
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP