Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06015542 |
| Other study ID # |
ERICA |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
January 1, 2026 |
Study information
| Verified date |
April 2024 |
| Source |
Odense University Hospital |
| Contact |
Jannie Kirkegaard, RN |
| Phone |
+45 29648494 |
| Email |
Jannie.kirkegaard[@]rsyd.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
Background Bispecific antibodies targeting CD3 and BCMA have demonstrated astonishing
efficacy with response rates of nearly 65 % in triple class exposed patients with multiple
myeloma (MM). This will not necessarily be the first product to be marketed, but might be a
product proven to be applicable for safe and convenient self-administration in the patients'
homes, thereby improving the patients' and their caregivers' Quality of Life (QoL) and
reducing the burden on the healthcare system. Although optimal dosing regimens are still
being investigated, most CD3xBCMA are given weekly until progression, with the possibility of
downscaling to twice monthly, if good remission is obtained. Consequently, patients have
multiple visits to the outpatient clinic, meaning that they spend a substantial amount of
time on transport, and that they are continuously exposed to potential infections.
Furthermore, the outpatient clinic might end out with many bispecific treatments in the
future, due to their high efficiency, thus straining the logistics of the hospital.
Previous studies have shown that patients who administer their treatment themselves
experience better QoL, a higher level of well-being, and have a higher level of daily
activity. In addition, socio-economic savings of up to 20-50% are seen with
self-administration compared to outpatient treatment.
Elranatamab is a bispecific CD3xBCMA with some unique properties; it is given subcutaneously
as a fixed dose, and it has shown a remarkably low risk of CRS after the third injection.
This makes it a perfect candidate to investigate in a setup, where patients are trained in
self-administration at their own homes.
Acquiring source data and planned visits In the study, Elranatamab will be administered as
monotherapy for six cycles of 28 days (Table 1). Patients will receive subcutaneous
Elranatamab 76 mg QW with a 2-step-up priming dose regimen administered during the first week
(12 mg D1 and 32 mg D4). For safety reasons, the step-up doses will be administered with
hospitalization for a minimum of 48hr (C1D1) and 24hr (C1D4), respectively. During
hospitalization, vital signs will be measured at least 6 times per overnight stay. If
treatment is tolerated, C1D8, C1D15 and C1D22 will be administered in the outpatient clinic
and will include training of the patients in self-administration. In cycle 2 to cycle 6,
patients will administer the treatment themselves in the outpatient clinic D1 and at home D8,
D15 and D22. However, if patients experience any CRS during the study, the consecutive two
doses must be administered in the outpatient clinic without any signs of CRS, before home
treatment can be resumed. If patients experience ICANS, they will be taken off study.
Prior to each new treatment cycle, laboratory assessments will be conducted at the local
hospital or at the patient's GP, according to general standards. A hematologist at Odense
University Hospital, who will also evaluate the patient, must accept the laboratory
assessments before D1 of all cycles.
Further, the following data will be collected to meet the secondary endpoints:
At inclusion, data on age, gender, marital status, PS, R-ISS, ISS, vital signs, myeloma type,
renal and liver function, concomitant medication (CM), weight, number of previous lines of
treatment and response to previous lines of treatment will be registered in an electronic
case report form (eCRF). Further, patients will be physically examined and cognitively
tested, which will include a writing test and a test of their ability to recognize known
pictures. Finally, patients must complete the EORTC QLQ-C30 and the FACT Cognitive
questionnaires electronically.
During planned hospitalization in cycle 1, patients will be continuously examined, and data
on PS, vital signs, results of blood samples, CM, AEs and results of CRS and ICANS screening
will be collected. Similar data will be collected at C1D8, C1D15 and C1D22.
Starting from cycle 2, data on location of administration will be collected. Specifically,
redirected administrations and discarded doses will be registered. When patients show in the
outpatient clinic at D1, they will be physically examined, and data on PS, vital signs,
results of blood samples, CM, AEs, weight and result of CRS and ICANS screening will be
collected. Further, patients should complete the EORTC QLQ-C30 electronically. If they do not
complete the questionnaire during their visit at the outpatient clinic, it can be completed
from home the following days, but no later than two days after treatment (D3).
Before each home administration (D8, D15 and D22), patients will receive an electronic
questionnaire on their physical and cognitive condition. They must answer if they have had a
fever (they will be instructed in measuring their temperature before every injection),
dizziness or any other sickness, or if they have received any antibiotics since their last
administration. Further, to rule out any grade of ICANS, they will be cognitively tested. The
questionnaire must be filled in within two days prior to the administration. On the day of
treatment, a specialized nurse from the outpatient clinic will assess the responses and call
the patient in the morning to make sure there are no unexpected problems or fever, which
would be incompatible with treatment.
At D1 (in the outpatient clinic) and D8 (at home) in cycle 2-6, patients, caregivers, nurses
and physicians in the outpatient clinic must register their time spent on the administration.
For patients and caregivers, this includes waiting time and time spent on transportation.
Further, they should register their mode of transportation and if they have had any need for
taking time off from work due to the planned administration. For nurses and physicians, this
includes both administrative and time spent with the patient.
Throughout the study, patients must register if they have had any unplanned contact with the
healthcare system (e.g. to with the Department of Hematology or their GP). For this purpose,
they will automatically be contacted electronically each week, and if they register any
unplanned contacts, a study nurse will contact them for clarification and register the cause
of the contact.
At EOT, patients and caregivers must complete a questionnaire on their preferences (treatment
at home or in the outpatient clinic). Moreover, patients must complete the EORTC QLQ-C30 and
FACT Cognitive questionnaires. Finally, patients and caregivers will be interviewed
individually.
At EOS, a focus group interview with involved health care professionals at the outpatient
clinic will be conducted.
Safety considerations and drug administration The most common AE associated with Elranatamab
is CRS. The treatments in the first cycle will be administered at the hospital; the two
priming doses with hospitalization and the others in the outpatient clinic. Further, to
reduce the grade of CRS, patients will receive premedications including corticosteroid,
antihistamine and antipyretic for both priming doses and for the first full dose. If no CRS
is observed, only antihistamine and antipyretic will be used in the following treatments.
Treatment will not be released for self-administration before cycle 2, at which time the risk
of severe CRS is considered minimal. Further, to reduce the risk of infections, patients will
receive infection prophylaxis in the form of Sulfametoxazole with Trimethoprim 80/400mg
daily, Ciprofloxacin 500mg twice daily, as well as immunoglobulin substitution, if polyclonal
IgG drops below 5 g/L.
Before each new treatment cycle is initiated, laboratory assessments will be conducted at the
local hospital or the patient's GP, according to general standards. A hematologist at Odense
University Hospital, who will also evaluate the patient, must accept the laboratory
assessments before treatment is released. Before each home administration (D8, D15 and D22),
the patient must answer an electronic questionnaire on their physical and cognitive
condition. This includes questions on whether they have had a fever, dizziness or any other
sickness, and if they have received any antibiotics since last their last administration).
Further, to rule out any grade of CRS or infection, patients will be instructed in measuring
their temperature before every injection and report the result electronically. Finally, to
rule out any grade of ICANS, they will be cognitively tested, which will include a writing
test and a test of their ability to recognize known pictures.
At the day of administration, a specialized nurse will assess the responses and call the
patient in the morning to make sure no unexpected problems or fever have occurred. If all
criteria are met, the nurse will contact the Hospital Pharmacy that will prepare the
treatment and send it directly to the patient by car.
CRS and ICANS Management of CRS and ICANS will be handled as per local guideline following
ASTCT guidelines.
If the patients experience CRS (any grade) at any time, the patients must receive the two
consecutive doses under observation at the hospital. Patients experiencing ICANS (any grade)
will be excluded from the study.
Side effects Registration and reporting of AE, SAE and SUSAR All protocol registered AEs,
SAEs and product quality complaints, whether serious or non-serious, related or not related,
collected as per national guidelines to the licensed medical holder (©Pfizer) will be
registered in the eCRF. SAEs will be assessed by PI as either Suspected Adverse Reaction
(SAR), Suspected Unexpected Serious Adverse Reactions (SUSAR) or non-related SAE. SARs and
SUSARs will be reported to the medical license holder within 24 hours of investigator
acknowledgement using the Investigator Sponsored Research or Clinical Research Collaboration
Interventional Study Serious Adverse Event Form V. 5.0. The form can be completed by a study
coordinator, but should be signed by PI (MD. PhD, Thomas Lund) as soon as possible. However,
the signature should not delay submission of the form beyond the 24 hours.
Non-related SAEs and AEs will be reported every third month to Pfizer and annually to the
Danish Medical Agency.
Side effects Registration and reporting of AE, SAE and SUSAR All protocol registered AEs,
SAEs and product quality complaints, whether serious or non-serious, related or not related,
collected as per national guidelines to the licensed medical holder (©Pfizer) will be
registered in the eCRF. SAEs will be assessed by PI as either Suspected Adverse Reaction
(SAR), Suspected Unexpected Serious Adverse Reactions (SUSAR) or non-related SAE. SARs and
SUSARs will be reported to the medical license holder within 24 hours of investigator
acknowledgement using the Investigator Sponsored Research or Clinical Research Collaboration
Interventional Study Serious Adverse Event Form V. 5.0. The form can be completed by a study
coordinator, but should be signed by PI (MD. PhD, Thomas Lund) as soon as possible. However,
the signature should not delay submission of the form beyond the 24 hours. The SAE form
should be sent to the following password-protected e-mail: DNK.AEReporting@pfizer.com
Non-related SAEs and AEs will be reported every third month to Pfizer and annually to the
Danish Medical Agency.
The NCI CTCAE v 4.0 is used for grading the severity of AEs. Each dose modification or
treatment delay, as well as the reason will be documented in the eCRF. AEs and SAEs will be
registered from first dose of treatment until 28 calendar days after the last dose of
Elranatamab in the study. In addition, any AE/SAE occurring after the 28-day period will also
be registered, if PI suspects a causal relationship between Elranatamab and the AE/SAE. Signs
or symptoms directly related to MM or planned hospitalization for earlier known diseases will
not be registered.
