Self-administration of Subcutaneous Elranatamab in the Patients' Homes.

NCT06015542 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ERICA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this open label, phase two, prospective, non-randomized, sponsor-initiated explorative trial is to test self-administration of subcutaneous Elranatamab in the patients' homes in patients with relapsed multiple myeloma exposed to at least one proteasome inhibitor, one IMID and one anti CD-38 antibody. The main question\[s\]it aims to answer are:

• To evaluate the safety of self-administration of Elranatamab in the patients' own homes using registrations of occurrence of CRS, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections.
• To evaluate the feasibility of self-administration of Elranatamab in the patients´ own homes by registration of discarded doses, planned doses administered at home and doses diverted from the patients' homes to the outpatient clinic.
• To elucidate the perspectives of patients and their caregivers of self-administration of Elranatamab at home by interviewing both parties at end of treatment (EOT).
• To elucidate the perspectives of involved healthcare professionals in a focus group interview at end of study (EOS).
• To clarify time spent on self-administration at home compared to administration at the outpatient clinic by registering time consumption for patients, caregivers and healthcare professionals.
• To evaluate the patients' QoL during self-administration using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) together with the Functional Assessment of Cancer Therapy-Cognitive (FACT Cognitive).
• To clarify if self-administration in the patients' homes leads to additional unplanned contacts with the healthcare system as a whole by weekly registration of any unplanned contacts.
• To determine financial costs of self-administration at home compared to administration at the outpatient clinic from the perspectives of patients, caregivers and the healthcare system by collecting data on lost earnings, transport costs and salary costs.
• To evaluate the feasibility of the use of an electronic registration of side effects prior to treatment by comparing electronic patient reported outcome (PRO) data to registrations performed by nurses in the outpatient clinic during telephone consultations. Participants will be asked to
• register time spend
• answer PRO-questionnaires
• weekly register any unplanned contact to the heathcare system
• be interviewed

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of self-administration of Elranatamab in the patients' own homes assessed by checklist

  Registrations of occurrence of CRS, Immune effector cell-associated neurotoxicity syndrome (ICANS) and infections.

  approximately 24 weeks

Secondary Outcomes (8)

• evaluate the feasibility of self-administration of Elranatamab in the patients´ own homes

  approximately 24 weeks

• elucidate the perspectives of patients and their caregivers of self-administration of Elranatamab at home

  approximately 1 hour

• elucidate the perspectives of involved healthcare professionals

  approximately 2 hours

• clarify time spent on self-administration at home compared to administration at the outpatient clinic

  approximately 24 weeks

• evaluate the patients' QoL during self-administration

  approximately 24 weeks

Study Arms (1)

Self-administration of Elranatamab

EXPERIMENTAL

It is a feasibility study assessing the feasibility and safety of self-administration of Elranatamab in the homes of the patients. The intervention of the study is self-administration of Elranatamab by the patient, thereby changing the administration from an outpatient setting to a home setting. The patients will function as their own controls, as treatment will be given alternately at home and in the outpatient clinic.

Drug: Elranatamab

Interventions

Elranatamab DRUG

Elranatamab will be administered as monotherapy for six cycles of 28 days. Elranatamab 76 mg will be administered QW with a 2-step-up priming dose regimen administered during the first week (12 mg D1 and 32 mg D4).

Also known as: PF-06863135

Self-administration of Elranatamab

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age at the time of signing the informed consent form.
• Relapsed MM according to the IMWG criteria.
• Measurable disease defined as: M-protein quantities ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) and/or Serum free light chain (FLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda (κ/λ) ratio in patients without measurable disease in the serum or urine.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2.
• Previously exposed to at least two of the following; one proteasome inhibitor, one IMID, or one anti CD-38 antibody.
• Documented disease progression during or after last anti-myeloma regimen.
• Possibility of being observed by a capable caregiver during self-administration.
• ANC ≥1.0 x 109/L (G-CSF allowed).
• Platelets ≥25 x 109/L.
• Female patients of childbearing potential must have a negative serum pregnancy test at screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

You may not qualify if:

• Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study.
• Prior history of ICANS.
• Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following non-invasive malignancies:
• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \[tumor, nodes and metastasis\] clinical staging system) or prostate cancer that is curative
• Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or clinically significant Amyloidosis.
• Female who is pregnant, breastfeeding or who intends to become pregnant during the participation in the study.
• Positivity for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C.
• Resident on an unbridged island.
• Not being able to register PRO-data electronically.

Sponsors & Collaborators

• Thomas Lund: lead
• Pfizer: collaborator
• Vejle Hospital: collaborator

Study Sites (2)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Department of Heamatology

Vejle, 7100, Denmark

RECRUITING

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

• Thomas Lund, MD

  Odense Universitetshospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jannie Kirkegaard, RN

CONTACT

+45 29648494; Jannie.kirkegaard@rsyd.dk

Tine Rosenberg, MSc

CONTACT

+45 21370942; tine.rosenberg@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: An open label, phase two, prospective, multi-center, non-randomized, sponsor-initiated explorative trial

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 29, 2023
• Study Start: January 29, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)