Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This study aims to assess the safety, tolerability and dosing of MEDI2888 for treatment of multiple myeloma in adults who are transplant ineligible or have recurrent Multiple Myeloma. Patients eligible to participate in this study will receive a specific dose of MEDI2228.
Conditions
This trial is treating people with Multiple Myeloma
Eligibility
Inclusion
- Subjects must be ≥ 18 years of age at the time of screening.
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Subjects must have a confirmed diagnosis of relapsed/refractory MM as per IMWG criteria (Rajkumar et al, 2014) and have exhausted standard of care regimens with proven clinical benefit, which include agents from the following anti myeloma therapies: PIs, IMIDs, and mAbs and have measurable disease with at least one of the following criteria:
- Serum M-protein ≥ 0.5 g/dL
- Urine M-protein ≥ 200 mg/24 hours
- Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal.
- Subjects must either be ineligible for or post-autologous stem cell transplant.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Adequate organ and marrow functions as determined per protocol-defined criteria.
Exclusion
Any of the following would exclude the subject from participation in the study:
Target Disease:
- Subjects who have previously received an autologous stem cell transplant if less than 90 days have elapsed from the time of transplant or the subject has not recovered from transplant associated toxicities prior to the first scheduled dose of MEDI2228
- Subjects who have previously received an allogeneic stem cell transplant
- Central nervous system (CNS) involvement(including meningeal involvement) by MRI or cerebrospinal fluid exam
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Known history of polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome, plasma cell leukemia, Waldenstrom's macroglobulinemia, or amyloidosis
Medical History and Concurrent Diseases:
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
MedImmune, LLC
Scientific Title
A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
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