MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma

MedImmune

Status and phase: Completed; Phase 1

Conditions: Relapsed/Refractory Multiple Myeloma

Treatments: Biological: Dose Escalation, MEDI2228, ADC (antibody drug conjugate); Biological: Dose Expansion, MEDI2228, ADC (antibody drug conjugate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03489525

D7900C00001

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 101 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Dose Escalation, MEDI2228, ADC

Experimental group

Description:

Single agent MEDI2228, ADC (antibody drug conjugate) will be administered to adult subjects with relapsed/refractory (R/R) multiple myeloma (MM).

Treatment:

Biological: Dose Escalation, MEDI2228, ADC (antibody drug conjugate)

Dose Expansion, MEDI2228, ADC

Experimental group

Description:

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.

Treatment:

Biological: Dose Expansion, MEDI2228, ADC (antibody drug conjugate)