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