Relapsed/Refractory Multiple MyelomaPhase 1MEDI2228NCT03489525
MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing Dose Escalation, MEDI2228, ADC (antibody drug conjugate) and Dose Expansion, MEDI2228, ADC (antibody drug conjugate) in people with Relapsed/Refractory Multiple Myeloma, run by MedImmune LLC at 11 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Dose Escalation, MEDI2228, ADC (antibody drug conjugate) and Dose Expansion, MEDI2228, ADC (antibody drug conjugate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 8 May 2018to 21 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be ≥ 18 years of age at the time of screening.
- 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.
Who cannot join
- 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
- 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
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States8 sites
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02215
Research Site
Charlotte, North Carolina, 28204
Research Site
Detroit, Michigan, 48201
Research Site
Fairfax, Virginia, 22031
Research Site
Jacksonville, Florida, 32224
Research Site
Phoenix, Arizona, 85054
Research Site
Rochester, Minnesota, 55905
About this study
Official 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
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.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- Dose Escalation, MEDI2228, ADC (antibody drug conjugate), Dose Expansion, MEDI2228, ADC (antibody drug conjugate)
- Keywords
- multiple myeloma, relapsed/refractory, open-label
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose Escalation, MEDI2228, ADC (antibody drug conjugate)Biological
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
Dose Expansion, MEDI2228, ADC (antibody drug conjugate)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation, MEDI2228, ADC | Experimental | Single agent MEDI2228, ADC (antibody drug conjugate) will be administered to adult subjects with relapsed/refractory (R/R) multiple myeloma (MM). Receives: Biological: Dose Escalation, MEDI2228, ADC (antibody drug conjugate) |
| Dose Expansion, MEDI2228, ADC | Experimental | 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. Receives: Biological: Dose Expansion, MEDI2228, ADC (antibody drug conjugate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs)
To assess by the occurrence of adverse events (AEs)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From time of informed consent and up to 21 days post end of treatment
Secondary outcomes (10)
MEDI2228 maximum observed concentration for PK
To assess the pharmacokinetics of MEDI2228
Measured: 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
Measured: From time of informed consent through 60 days post end of treatment
MEDI2228 clearance for PK
To assess the pharmacokinetics of Medi2228
Measured: From time of informed consent through 60 days post end of treatment
MEDI2228 terminal half-life for PK
To assess the pharmacokinetics of MEDI2228
Measured: 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
Measured: From time of informed consents through 60 days post end of treatment
Objective response rate (ORR)
To assess the anti-tumor activity of MEDI2228
Measured: From time of informed consent and up to three years after final patient is enrolled
Clinical benefit rate
To assess clinical benefit of MEDI2228
Measured: 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
Measured: 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
Measured: 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
Measured: From time of informed consent and up to three years after final patient is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start8 May 2018
- Primary completion21 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medimmune LLC, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489525
- Sponsor's protocol ID
- D7900C00001
- Acronym
- MEDI2228
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2018
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03489525
- Acronym / sponsor ID
- MEDI2228 / D7900C00001
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Keywords
- multiple myeloma, relapsed/refractory, open-label
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 8 May 2018 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation, MEDI2228, ADC | Experimental | Biological: Dose Escalation, MEDI2228, ADC (antibody drug conjugate)Single agent MEDI2228, ADC (antibody drug conjugate) will be administered to adult subjects with relapsed/refractory (R/R) multiple myeloma (MM). |
| Dose Expansion, MEDI2228, ADC | Experimental | Biological: Dose Expansion, 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. |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be ≥ 18 years of age at the time of screening.
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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
- Known history of polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome, plasma cell leukemia, Waldenstrom's macroglobulinemia, or amyloidosis
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Dose Escalation, MEDI2228, ADC |
| 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. | Biological | Dose Expansion, MEDI2228, ADC |
Primary outcome
Occurrence of adverse events (AEs)
Time frame: From time of informed consent through 90 days post end of treatment
To assess by the occurrence of adverse events (AEs)
Occurrence of SAE (serious adverse events)
Time frame: From time of informed consent through 90 days post end of treatment
To assess the occurrence of serious adverse events (SAEs)
Occurrence of DLTs (dose limiting toxicities)
Time frame: From time of informed consent through 90 days post end of treatment
To assess by the occurrence of hematologic and non-hematologic toxicities, AEs, and abnormal laboratory results
Number of patients with changes in laboratory parameters from baseline
Time frame: From time of informed consent and up to 21 days post end of treatment
To assess serum chemistry, hematology, coagulation and urninalysis
Number of patients with changes in vital signs from baseline
Time frame: From time of informed consent and up to 21 days post end of treatment
To assess body temperature, blood pressure and heart rate
Number of patients with changes in elctrocardiogram (ECG) results from baseline
Time frame: From time of informed consent and up to 21 days post end of treatment
To assess using 12 lead ECG recordings
10 secondary outcomes
MEDI2228 maximum observed concentration for PK
Time frame: From time of informed consent through 60 days post end of treatment
MEDI2228 area under the concentration-time curve for PK
Time frame: From time of informed consent through 60 days post end of treatment
MEDI2228 clearance for PK
Time frame: From time of informed consent through 60 days post end of treatment
MEDI2228 terminal half-life for PK
Time frame: From time of informed consent through 60 days post end of treatment
Number of subjects who develop anti-drug antibodies (ADAs)
Time frame: From time of informed consents through 60 days post end of treatment
Objective response rate (ORR)
Time frame: From time of informed consent and up to three years after final patient is enrolled
Clinical benefit rate
Time frame: From time of informed consent up to three years after final patient is enrolled
Duration of response (DoR)
Time frame: From time of informed consent and up to three years after final patient is enrolled
Progression free survival (PFS)
Time frame: From time of informed consent and up to three years after final patient is enrolled
Overall Survival (OS)
Time frame: From time of informed consent and up to three years after final patient is enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medimmune LLC study director
Sponsor GmbH
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose Escalation, MEDI2228, ADC (antibody drug conjugate) and Dose Expansion, MEDI2228, ADC (antibody drug conjugate) in people with Relapsed/Refractory Multiple Myeloma, run by MedImmune LLC at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia, Greece, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (AEs) (time frame: From time of informed consent through 90 days post end of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.