Clinical Trials /

MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma

NCT03489525

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: D7900C00001
  • NCT ID: NCT03489525

Conditions

  • Relapsed/Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
Dose Escalation, MEDI2228, ADC (antibody drug conjugate)Dose Escalation, MEDI2228, ADC
Dose Expansion, MEDI2228, ADC (antibody drug conjugate)Dose Expansion, MEDI2228, ADC

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation, MEDI2228, ADCExperimentalSingle agent MEDI2228, ADC (antibody drug conjugate) will be administered to adult subjects with relapsed/refractory (R/R) multiple myeloma (MM).
  • Dose Escalation, MEDI2228, ADC (antibody drug conjugate)
Dose Expansion, MEDI2228, ADCExperimentalSingle 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.
  • Dose Expansion, MEDI2228, ADC (antibody drug conjugate)

Eligibility Criteria

        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
      
Maximum Eligible Age:101 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Occurrence of adverse events (AEs)
Time Frame:From time of informed consent through 90 days post end of treatment
Safety Issue:
Description:To assess by the occurrence of adverse events (AEs)

Secondary Outcome Measures

Measure:MEDI2228 maximum observed concentration for PK
Time Frame:From time of informed consent through 60 days post end of treatment
Safety Issue:
Description:To assess the pharmacokinetics of MEDI2228
Measure:MEDI2228 area under the concentration-time curve for PK
Time Frame:From time of informed consent through 60 days post end of treatment
Safety Issue:
Description:To assess the pharmacokinetics of MEDI2228
Measure:MEDI2228 clearance for PK
Time Frame:From time of informed consent through 60 days post end of treatment
Safety Issue:
Description:To assess the pharmacokinetics of Medi2228
Measure:MEDI2228 terminal half-life for PK
Time Frame:From time of informed consent through 60 days post end of treatment
Safety Issue:
Description:To assess the pharmacokinetics of MEDI2228
Measure:Number of subjects who develop anti-drug antibodies (ADAs)
Time Frame:From time of informed consents through 60 days post end of treatment
Safety Issue:
Description:To assess immunogenicity of MEDI2228
Measure:Objective response rate (ORR)
Time Frame:From time of informed consent and up to three years after final patient is enrolled
Safety Issue:
Description:To assess the anti-tumor activity of MEDI2228
Measure:Clinical benefit rate
Time Frame:From time of informed consent up to three years after final patient is enrolled
Safety Issue:
Description:To assess clinical benefit of MEDI2228
Measure:Duration of response (DoR)
Time Frame:From time of informed consent and up to three years after final patient is enrolled
Safety Issue:
Description:To assess the anti-tumor activity of MEDI2228
Measure:Progression free survival (PFS)
Time Frame:From time of informed consent and up to three years after final patient is enrolled
Safety Issue:
Description:To assess the anti-tumor activity of MEDI2228
Measure:Overall Survival (OS)
Time Frame:From time of informed consent and up to three years after final patient is enrolled
Safety Issue:
Description:To assess the anti-tumor activity of MEDI2228

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:MedImmune LLC

Trial Keywords

  • multiple myeloma
  • relapsed/refractory
  • open-label

Last Updated

November 21, 2019