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Trial record 3 of 242 for:    Refractory | Recruiting, Not yet recruiting, Available Studies | "Multiple Myeloma"

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

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ClinicalTrials.gov Identifier: NCT03489525
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

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.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Biological: Dose Escalation, MEDI2228, ADC (antibody drug conjugate) Biological: Dose Expansion, MEDI2228, ADC (antibody drug conjugate) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description: Open-label
Primary Purpose: Treatment
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
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : April 23, 2021
Estimated Study Completion Date : April 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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).
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

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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) or intolerant to all established regimens with proven clinical benefit, which include agents from the following 3 classes of 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489525


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, Arizona
Research Site Recruiting
Phoenix, Arizona, United States, 85054
United States, Florida
Research Site Recruiting
Jacksonville, Florida, United States, 32224
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02114
Research Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Research Site Recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Research Site Recruiting
Rochester, Minnesota, United States, 55905
United States, North Carolina
Research Site Recruiting
Charlotte, North Carolina, United States, 28204
Australia
Research Site Recruiting
Melbourne, Australia, 3004
Greece
Research Site Recruiting
Athens, Greece, 11528
Sponsors and Collaborators
MedImmune LLC
Investigators
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Study Director: Medimmune LLC Sponsor GmbH

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT03489525     History of Changes
Other Study ID Numbers: D7900C00001
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by MedImmune LLC:
multiple myeloma
relapsed/refractory
open-label

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs