Self-administration of subcutaneous Elranatamab in the patients’ homes (ERICA)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

4 Sep 2024 → ongoing

Decision date (initial)

2024-07-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-507876-30-00

ClinicalTrials.gov

NCT06015542

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

To evaluate the feasibility of self-administration of Elranatamab in the patients´ homes
To evaluate the safety of self-administration of Elranatamab in the patients’ homes

Secondary objectives 13

1. To evaluate the risk of infections during treatment with elranatamab
2. To evaluate the safety of self-administration of Elranatamab in the outpatient clinic
3. To evaluate the effect of Elranatamab treatment
4. To evaluate the feasibility of the use of an electronic registration of side effects prior to treatment
5. To clarify time spent on self-administration at home compared to administration at the outpatient clinic
6. To clarify if self-administration in the patients’ homes leads to additional unplanned contacts with the healthcare system as a whole
7. To assess how self-administration of elranatamab in the patients’ home affects quality of life
8. To evaluate the influence of treatment with elranatamab on perceived cognitive function
9. To evaluate the reversibility of perceived cognitive impairment
10. To evaluate the impact on the quality of life of caregivers to patients with MM administering their anti-MM treatment themselves at home
11. To characterize temporal changes in the T cell compartment during elranatamab treatment and put them into the context of T cell function, in order to define a threshold upon which continuous administration of elranatamab is deleterious and where a treatment pause (drug holidays) could revert T cell exhaustion
12. To define the baseline characteristics of T cell compartment and TME that are associated with primary resistance to elranatamab therapy
13. To define spatial characteristics of T cell compartment and TME that are associated with primary and secondary resistance to elranatamab therapy.

Conditions and MedDRA coding

Multiple Myeloma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. ≥ 18 years of age at the time of signing the informed consent form
2. Able to read and understand the Danish language
3. Relapsed MM according to the IMWG criteria
4. 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
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2
6. Previously exposed to at least two of the following: one proteasome inhibitor, one Immunomodulatory drugs (IMID), or one anti CD-38 antibody
7. Documented disease progression during or after last anti-myeloma regimen
8. Possibility of being observed by a capable caregiver during self-administration, to react appropriately if necessary
9. ANC ≥1.0 x 109/L (G-CSF allowed)
10. Platelets ≥25 x 109/L
11. 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.

Exclusion criteria 8

1. Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from participating in the study
2. Prior BCMA targeted treatment
3. Prior history of ICANS
4. 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
5. Plasma cell leukemia, Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes), or clinically significant Amyloidosis
6. Female who is pregnant, breastfeeding, or who intends to become pregnant during the participation in the study
7. Positivity for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis A or C
8. Resident on an unbridged island

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Number of discarded doses, planned doses administered at home, and doses diverted from the patients’ homes to the outpatient clinic evaluated at EoP1
2. Incidence and severity of AEs and SAEs evaluated at EoP1. AEs/SAEs will be graded according to NCI CTCAE v5.0. CRS and ICANS will be graded according to ASTCT consensus grading

Secondary endpoints 10

1. Number of infections requiring medical attention or hospitalization assessed at EoP1
2. Incidence and severity of AEs and SAEs evaluated at EoP2. AEs/SAEs will be graded according to NCI CTCAE v5.0. CRS and ICANS will be graded according to ASTCT consensus grading
3. Overall Response Rate (ORR) and duration of response at EoP2 with response defined according to IMWG response criteria
4. PPV and NPV of self-reporting of side effects assessed at EoP1
5. Time consumption for patients, caregivers, and healthcare professionals assessed at EoP1
6. Number of unplanned contacts to the healthcare system assessed at EoP1
7. Number of patients reporting improved or impaired quality of life at C3D1 and EoP1 compared to baseline using the EORTC QLQ-C30 and MY20
8. Number of patients developing cognitive impairment during elranatamab treatment assessed at EoP1 by the FACT-Cog domain of perceived cognitive impairments
9. Number of patients developing perceived cognitive impairment, who recover from perceived cognitive impairment based on the following FACT-Cog assessments assessed at EoP1
10. Number of caregivers experiencing their quality of life to be affected to a higher degree at C3D1 and EoP1 compared to baseline assessed by FROM-16

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J B Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

Department of Hematology

Public contact point

Organisation

Odense University Hospital

Contact name

Department of Hematology

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications