Study of Daratumumab (JNJ-54767414 (HuMax® CD38) in Combination with VELCADE, Thalidomide. and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects with Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma10018865
- Registration Number
- NL-OMON55990
- Lead Sponsor
- Intergroupe Francophone du Myelome (IFM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
- 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
- previous treatment for Multiple Myeloma
- Primary amyloidosis, Plasma Cell Leukemia or Smoldering Multiple Myeloma
- Prior or concurrent exposure to systemic therapy or SCT 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. The percentage of participants who achieve a stringent complete response<br /><br>(sCR) after consolidation therapy<br /><br>2. The percentage of increase in progression free survival after maintenance<br /><br>therapy</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. PFS (from first randomization)<br /><br>2.Time to progression (TTP)<br /><br>3.Post-ASCT/ consolidation CR rate<br /><br>4.Post-ASCT/consolidation MRD negative rate<br /><br>5.Post-induction sCR rate<br /><br>6.PFS2 (from first randomization)<br /><br>7.OS (from first randomization)</p><br>