Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06015542

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

Led by Thomas Lund · Updated on 2026-02-10

20

Participants Needed

2

Research Sites

126 weeks

Total Duration

On this page

Sponsors

T

Thomas Lund

Lead Sponsor

P

Pfizer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older at the time of signing informed consent
  • Diagnosis of relapsed multiple myeloma according to IMWG criteria
  • Measurable disease defined by specific protein levels in blood or urine or abnormal serum free light chain levels
  • ECOG performance status 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 treatment
  • Ability to be observed by a capable caregiver during self-administration
  • Absolute neutrophil count (ANC) of at least 1.0 x 10^9/L (G-CSF allowed)
  • Platelet count of at least 25 x 10^9/L
  • Female patients of childbearing potential must have a negative 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 contraception during the study and for 3 months after last treatment dose
Not Eligible

You will not qualify if you...

  • Any significant medical condition, abnormal lab result, or psychiatric illness preventing participation
  • Prior history of immune effector cell-associated neurotoxicity syndrome (ICANS)
  • Prior history of malignancies other than multiple myeloma, unless disease-free for at least 5 years, except for certain non-invasive skin and cervical cancers and specific prostate cancer conditions
  • Diagnosis of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or clinically significant amyloidosis
  • Pregnant, breastfeeding, or intending to become pregnant during the study
  • Positive for HIV, chronic or active hepatitis B, or active hepatitis A or C
  • Resident on an unbridged island
  • Inability to register patient-reported outcome data electronically

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

2

Department of Heamatology

Vejle, Denmark, 7100

Actively Recruiting

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Research Team

J

Jannie Kirkegaard, RN

CONTACT

T

Tine Rosenberg, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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