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Completed

NCT Number: NCT03489525

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.

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Key information

Conditions

Relapsed/Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year–101 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Melbourne, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. 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

  3. MEDI2228 clearance for PK

    Time frame: From time of informed consent through 60 days post end of treatment

    To assess the pharmacokinetics of Medi2228

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study 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

Acronym: MEDI2228

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2018
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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