Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma (MEDI2228)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03489525
Recruitment Status : Active, not recruiting
First Posted : April 5, 2018
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE March 17, 2018
First Posted Date  ICMJE April 5, 2018
Last Update Posted Date November 11, 2021
Actual Study Start Date  ICMJE May 8, 2018
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2018)
  • MEDI2228 maximum observed concentration for PK [ Time Frame: From time of informed consent through 60 days post end of treatment ]
    To assess the pharmacokinetics of MEDI2228
  • MEDI2228 area under the concentration-time curve for PK [ Time Frame: From time of informed consent through 60 days post end of treatment ]
    To assess the pharmacokinetics of MEDI2228
  • MEDI2228 clearance for PK [ Time Frame: From time of informed consent through 60 days post end of treatment ]
    To assess the pharmacokinetics of Medi2228
  • MEDI2228 terminal half-life for PK [ Time Frame: From time of informed consent through 60 days post end of treatment ]
    To assess the pharmacokinetics of MEDI2228
  • Number of subjects who develop anti-drug antibodies (ADAs) [ Time Frame: From time of informed consents through 60 days post end of treatment ]
    To assess immunogenicity of MEDI2228
  • Objective response rate (ORR) [ Time Frame: From time of informed consent and up to three years after final patient is enrolled ]
    To assess the anti-tumor activity of MEDI2228
  • Clinical benefit rate [ Time Frame: From time of informed consent up to three years after final patient is enrolled ]
    To assess clinical benefit of MEDI2228
  • Duration of response (DoR) [ Time Frame: From time of informed consent and up to three years after final patient is enrolled ]
    To assess the anti-tumor activity of MEDI2228
  • Progression free survival (PFS) [ Time Frame: From time of informed consent and up to three years after final patient is enrolled ]
    To assess the anti-tumor activity of MEDI2228
  • Overall Survival (OS) [ Time Frame: From time of informed consent and up to three years after final patient is enrolled ]
    To assess the anti-tumor activity of MEDI2228
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
Official Title  ICMJE A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
Brief 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 myeloma who are either transplant ineligible or post autologous stem cell transplant and are relapsed/refractory.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description:
Open-label
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Multiple Myeloma
Intervention  ICMJE
  • Biological: 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 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.
Study Arms  ICMJE
  • 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).
    Intervention: Biological: Dose Escalation, MEDI2228, ADC (antibody drug conjugate)
  • 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.
    Intervention: Biological: Dose Expansion, MEDI2228, ADC (antibody drug conjugate)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 21, 2021)
107
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2018)
129
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 101 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Greece,   Spain,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT03489525
Other Study ID Numbers  ICMJE D7900C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medimmune LLC Sponsor GmbH
PRS Account MedImmune LLC
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP