A Phase 1 interventional study of Dose Escalation, MEDI2228, ADC (antibody drug conjugate) and Dose Expansion, MEDI2228, ADC (antibody drug conjugate) in Relapsed/Refractory Multiple Myeloma, sponsored by MedImmune LLC. Completed at 11 sites in 4 countries. Open to participants aged 18 Years to 101 Years. Per ClinicalTrials.gov, last updated 2022-03-28.
Sponsored by MedImmune LLC (part of AstraZeneca) · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the safety, pharmacokinetics and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI2228 in adult subjects with multiple myeloma who are either transplant ineligible or post autologous stem cell transplant and are relapsed/refractory.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 107 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →MedImmune LLC is the lead sponsor of 270 studies on the registry; none are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 29 (56%) have results posted.
First submitted after MedImmune LLC became part of AstraZeneca.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must have a confirmed diagnosis of 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 with at least one of the following criteria:
Exclusion Criteria
Any of the following would exclude the subject from participation in the study:
Target Disease:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single agent MEDI2228, ADC (antibody drug conjugate) will be administered to adult subjects with relapsed/refractory (R/R) multiple myeloma (MM).
Biological: Dose Escalation, MEDI2228, ADC (antibody drug conjugate)
Single agent MEDI2228, ADC (antibody drug conjugate) will be administered to adult subjects with R/R MM in the dose-expansion cohort at the dose selected for evaluation in the dose-expansion phase.
Biological: Dose Expansion, MEDI2228, ADC (antibody drug conjugate)
Single agent MEDI2228 will be administered to adult subjects with R/R MM. The study aims to evaluate up to 9 planned, sequentially ascending main dose levels
Adult subjects with R/R MM with measurable disease will be enrolled in the dose-expansion cohort at the dose selected for evaluation in the dose-expansion phase.
Occurrence of adverse events (AEs)
To assess by the occurrence of adverse events (AEs)
Time frame: From time of informed consent through 90 days post end of treatment
Occurrence of SAE (serious adverse events)
To assess the occurrence of serious adverse events (SAEs)
Time frame: From time of informed consent through 90 days post end of treatment
Occurrence of DLTs (dose limiting toxicities)
To assess by the occurrence of hematologic and non-hematologic toxicities, AEs, and abnormal laboratory results
Time frame: From time of informed consent through 90 days post end of treatment
Number of patients with changes in laboratory parameters from baseline
To assess serum chemistry, hematology, coagulation and urninalysis
Time frame: From time of informed consent and up to 21 days post end of treatment
Number of patients with changes in vital signs from baseline
To assess body temperature, blood pressure and heart rate
Time frame: From time of informed consent and up to 21 days post end of treatment
Number of patients with changes in elctrocardiogram (ECG) results from baseline
To assess using 12 lead ECG recordings
Time frame: From time of informed consent and up to 21 days post end of treatment
MEDI2228 maximum observed concentration for PK
To assess the pharmacokinetics of MEDI2228
Time frame: From time of informed consent through 60 days post end of treatment
MEDI2228 area under the concentration-time curve for PK
To assess the pharmacokinetics of MEDI2228
Time frame: From time of informed consent through 60 days post end of treatment
MEDI2228 clearance for PK
To assess the pharmacokinetics of Medi2228
Time frame: From time of informed consent through 60 days post end of treatment
MEDI2228 terminal half-life for PK
To assess the pharmacokinetics of MEDI2228
Time frame: From time of informed consent through 60 days post end of treatment
Number of subjects who develop anti-drug antibodies (ADAs)
To assess immunogenicity of MEDI2228
Time frame: From time of informed consents through 60 days post end of treatment
Objective response rate (ORR)
To assess the anti-tumor activity of MEDI2228
Time frame: From time of informed consent and up to three years after final patient is enrolled
Clinical benefit rate
To assess clinical benefit of MEDI2228
Time frame: From time of informed consent up to three years after final patient is enrolled
Duration of response (DoR)
To assess the anti-tumor activity of MEDI2228
Time frame: From time of informed consent and up to three years after final patient is enrolled
Progression free survival (PFS)
To assess the anti-tumor activity of MEDI2228
Time frame: From time of informed consent and up to three years after final patient is enrolled
Overall Survival (OS)
To assess the anti-tumor activity of MEDI2228
Time frame: From time of informed consent and up to three years after final patient is enrolled
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca/MedImmune group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Time frame: AstraZeneca/MedImmune will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca/MedImmune will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Mar 2022, 46 months.
Of 212 industry-sponsored phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's 46 months is close to that.
Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Antibody-drug conjugates (ADCs)