A Study of Subcutaneous (SC) AMG 701 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT04998747 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 20200446
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to evaluate the safety and tolerability of subcutaneous (SC) AMG 701 in participants with relapsed or refractory multiple myeloma (RRMM) to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

AMG 701; Relapsed/Refractory Multiple Myeloma; B-cell maturation antigen (BCMA)

Outcome Measures

Primary Outcomes (6)

• Number of participants who experience dose-limiting toxicities (DLTs)

  28 days

• Number of participants who experience one or more treatment-emergent adverse events (TEAEs)

  up to approximately 9 months

• Number of participants who experience one or more treatment-related TEAEs

  up to approximately 9 months

• Number of participants with abnormal changes in vital signs

  up to approximately 9 months

• Number of participants with abnormal changes in electrocardiograms (ECGs) findings

  up to approximately 9 months

• Number of participants with abnormal changes in clinical laboratory tests

  up to approximately 9 months

Secondary Outcomes (11)

• Maximum serum concentration (Cmax) of AMG 701

  up to approximately 8 months

• Time to maximum concentration (Tmax) of AMG 701

  up to approximately 8 months

• Area under the concentration-time curve (AUC) of AMG 701

  up to approximately 8 months

• Minimum concentration over the dosing interval (Ctrough) of AMG 701

  up to approximately 8 months

• Incidence of anti-AMG 701 antibody formation

  up to approximately 9 months

Study Arms (2)

AMG 701: dose exploration

EXPERIMENTAL

Cohorts of 3 to 6 participants each will be administered AMG 701 at different doses to determine the RP2D based on occurence of dose-limiting toxicities (DLTs) and on emerging safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy data.

Drug: AMG 701

AMG 701: dose expansion

EXPERIMENTAL

Participants will be administered AMG 701 at the RP2D determined from dose exploration stage to further assess the safety, PK, PD, and efficacy of the selected dose.

Drug: AMG 701

Interventions

AMG 701 DRUG

AMG 701 will be administered as SC or intravenous injection.

AMG 701: dose exploration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• Age 18 years or older at the time of signing the informed consent.
• Relapsed or relapsed and refractory multiple myeloma according to International Myeloma Working Group (IMWG) criteria.
• Participants must have received ≥ 3 prior therapies that must include all approved and available therapies deemed eligible by the investigator, including at a minimum, a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and a CD38-directed antibody. Note: Participants may have received prior treatment targeting BCMA that is not AMG 701.
• Participants must have measurable disease, defined by 1 or more of the following at time of screening :
• A serum M protein ≥ 0.5 g/dL measured by serum protein electrophoresis (SPEP)
• Urinary M protein excretion ≥ 200 mg/24 hours
• Involved serum free light chain (sFLC) measurement ≥ 10 mg/dL, provided that SFLC ratio is abnormal as per IMWG response criteria
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
• Life expectancy of at least 3 months as per investigator's judgment at time of screening
• Hematological function without transfusion support as follows:
• Absolute neutrophil count ≥ 1.0 x 10\^9/L (without growth factor support)
• Platelet count ≥ 50 x 10\^9/L (without transfusions within 7 days from screening assessment)
• Hemoglobin ≥ 8.0 g/dL (transfusions permitted no later than 48 hours before screening)
• Renal function as follows:

You may not qualify if:

• Known central nervous system involvement by multiple myeloma.
• Recent history of primary plasma cell leukemia (within last 6 months prior to enrollment) or evidence of primary or secondary plasma cell leukemia at the time of screening.
• Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes), or amyloidosis (participants with multiple myeloma with asymptomatic amyloid plaques found on biopsy would be eligible if all other criteria are met).
• History or evidence of any of the following cardiovascular disorders:
• Active congestive heart failure (New York Heart Association Class III to IV)
• Symptomatic ischemia
• Uncontrolled arrhythmias
• Screening ECG with corrected QT interval (QTc) of \> 470 msec
• Myocardial infarction within 12 months prior to study day 1
• History of malignancy other than multiple myeloma within the past 3 years with the following exceptions:
• Malignancy treated with curative intent and with no known active disease present for at least 1 year before enrollment and felt to be at low risk for recurrence by the treating physician.
• Adequately treated cervical carcinoma in situ without evidence of disease.
• Breast ductal carcinoma in situ with full surgical resection (ie, negative margins) and without evidence of disease
• Prostate cancer with a Gleason score \< 7 with undetectable prostate specific antigen over 12 months
• Treated medullary or papillary thyroid cancer

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 10, 2021
• Study Start: August 29, 2023
• Primary Completion: August 2, 2025
• Study Completion: August 28, 2025
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.