Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celgene
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must have measurable disease as defined by m-protein or serum free light chain.
Must have failed last line of treatment (refractory to last line of treatment).
Must have achieved at least a minimal response (MR) to at least 1 prior anti-myeloma regimen before developing PD (relapsed)
Has performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Must be at least 18 years of age
You may not be if
Has non-secretory multiple myeloma
Has had prior anti-myeloma therapy within 2 weeks prior to study Day 1
Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1), antiprogrammed death-ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
Has received prior treatment with daratumumab or other anti-CD38 therapies previously
Has undergone prior organ or allogeneic hematopoetic stem cell transplantation
Has received autologous stem cell transplantation (ASCT) within 12 weeks before the date of randomization.
Has received prior treatment with a monoclonal antibody within 5 half-lives of Study Day 1
Has received investigational agents within 28 days or 5 half-lives (whichever is longer) of Study Day 1
Has received live, attenuated vaccine within 30 days prior to Study Day 1
Has chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal
Has moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification.
Is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C
Has a prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years (with the exception Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer \[T1a or T1b\] or prostate cancer that is curative)
Has clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma
Has clinically significant cardiac disease
Is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study
Clareo Health | A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
