Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oncopeptides AB
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A prior diagnosis of multiple myeloma with documented disease progression after the last line of therapy
Double refractory to an IMiD and a PI (regardless of the number of prior lines of therapy) or have received at least 3 prior lines of therapy including an IMiD and a PI
Prior treatment with daratumumab or another anti-CD38 antibody may be allowed under certain circumstances:
* Achieved at least partial response (PR) and not refractory to an anti-CD38 antibody
* At least 6 months since the last dose of anti-CD38 antibody
* Not discontinued anti-CD38 antibody treatment due to related Grade ≥ 3 toxicity
Male and female of childbearing potential agree to use contraception during the treatment period and at least 3 months after the last dose
You may not be if
Primary refractory disease (i.e., never responded with at least Minimal Response to any prior therapy for multiple myeloma)
Prior treatment with CD38 CAR-T cell therapy or CD38/CD3 bispecific antibodies
Any medical condition that may interfere with safety or participation in this study
Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast, or very low and low-risk prostate cancer in active surveillance
Known or suspected amyloidosis, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Known central nervous system (CNS) or meningeal involvement of myeloma
Prior stem cell transplant (autologous and/or allogenic) within 6 months of initiation of therapy or prior allogeneic stem cell transplantation with active graft-versus-host-disease