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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03489525




Registration number
NCT03489525
Ethics application status
Date submitted
17/03/2018
Date registered
5/04/2018

Titles & IDs
Public title
MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
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
Secondary ID [1] 0 0
D7900C00001
Universal Trial Number (UTN)
Trial acronym
MEDI2228
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Dose Escalation, MEDI2228, ADC (antibody drug conjugate)
Treatment: Other - Dose Expansion, MEDI2228, ADC (antibody drug conjugate)

Experimental: Dose Escalation, MEDI2228, ADC - Single agent MEDI2228, ADC (antibody drug conjugate) will be administered to adult subjects with relapsed/refractory (R/R) multiple myeloma (MM).

Experimental: Dose Expansion, MEDI2228, ADC - 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.


Treatment: Other: Dose Escalation, 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

Treatment: Other: Dose Expansion, MEDI2228, ADC (antibody drug conjugate)
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of adverse events (AEs)
Timepoint [1] 0 0
From time of informed consent through 90 days post end of treatment
Primary outcome [2] 0 0
Occurrence of SAE (serious adverse events)
Timepoint [2] 0 0
From time of informed consent through 90 days post end of treatment
Primary outcome [3] 0 0
Occurrence of DLTs (dose limiting toxicities)
Timepoint [3] 0 0
From time of informed consent through 90 days post end of treatment
Primary outcome [4] 0 0
Number of patients with changes in laboratory parameters from baseline
Timepoint [4] 0 0
From time of informed consent and up to 21 days post end of treatment
Primary outcome [5] 0 0
Number of patients with changes in vital signs from baseline
Timepoint [5] 0 0
From time of informed consent and up to 21 days post end of treatment
Primary outcome [6] 0 0
Number of patients with changes in elctrocardiogram (ECG) results from baseline
Timepoint [6] 0 0
From time of informed consent and up to 21 days post end of treatment
Secondary outcome [1] 0 0
MEDI2228 maximum observed concentration for PK
Timepoint [1] 0 0
From time of informed consent through 60 days post end of treatment
Secondary outcome [2] 0 0
MEDI2228 area under the concentration-time curve for PK
Timepoint [2] 0 0
From time of informed consent through 60 days post end of treatment
Secondary outcome [3] 0 0
MEDI2228 clearance for PK
Timepoint [3] 0 0
From time of informed consent through 60 days post end of treatment
Secondary outcome [4] 0 0
MEDI2228 terminal half-life for PK
Timepoint [4] 0 0
From time of informed consent through 60 days post end of treatment
Secondary outcome [5] 0 0
Number of subjects who develop anti-drug antibodies (ADAs)
Timepoint [5] 0 0
From time of informed consents through 60 days post end of treatment
Secondary outcome [6] 0 0
Objective response rate (ORR)
Timepoint [6] 0 0
From time of informed consent and up to three years after final patient is enrolled
Secondary outcome [7] 0 0
Clinical benefit rate
Timepoint [7] 0 0
From time of informed consent up to three years after final patient is enrolled
Secondary outcome [8] 0 0
Duration of response (DoR)
Timepoint [8] 0 0
From time of informed consent and up to three years after final patient is enrolled
Secondary outcome [9] 0 0
Progression free survival (PFS)
Timepoint [9] 0 0
From time of informed consent and up to three years after final patient is enrolled
Secondary outcome [10] 0 0
Overall Survival (OS)
Timepoint [10] 0 0
From time of informed consent and up to three years after final patient is enrolled

Eligibility
Key inclusion criteria
1. Subjects must be = 18 years of age at the time of screening.
2. 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:

1. Serum M-protein = 0.5 g/dL
2. Urine M-protein = 200 mg/24 hours
3. Serum free light chain (FLC) assay: involved FLC level = 10 mg/dL provided serum FLC ratio is abnormal.
3. Subjects must either be ineligible for or post-autologous stem cell transplant.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
5. Adequate organ and marrow functions as determined per protocol-defined criteria.
Minimum age
18 Years
Maximum age
101 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Any of the following would exclude the subject from participation in the study:

Target Disease:

1. 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
2. Subjects who have previously received an allogeneic stem cell transplant
3. Central nervous system (CNS) involvement(including meningeal involvement) by MRI or cerebrospinal fluid exam
4. 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:
5. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/03/2022
Sample size
Target
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Greece
State/province [8] 0 0
Athens
Country [9] 0 0
Spain
State/province [9] 0 0
Badalona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medimmune LLC
Address 0 0
Sponsor GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03489525