Trial Title:
Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT06421675
Condition:
Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
relapsed
refractory
multiple myeloma
elranatamab
cytokine release syndrome
immune effector-cell associated neurotoxicity
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Multi-center, single-arm, phase II study of single-agent elranatamab in patients with
relapsed and/or refractory multiple myeloma.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Elranatamab injection
Description:
Elranatamab (Elrexfio) is a humanized bispecific antibody that targets both
BCMA-expressing multiple myeloma (MM) cells and CD3-expressing T cells.
Arm group label:
Elranatamab injection
Other name:
Elrexio
Summary:
A phase II study of single agent elranatamab in patients with relapsed and/or refractory
multiple myeloma (MM) who have previously received at least three classes of therapeutic
agents and are refractory to the last line of treatment. The primary objective of this
study is to improve the tolerability and safety of elranatamab in patients with relapsed
and/or refractory multiple myeloma by evaluating an outpatient and intermittent dosing
strategy.
Detailed description:
This is a multi-centre, single arm, phase II study of single agent elranatamab in
patients with relapsed and/or refractory multiple myeloma (MM) who have previously
received at least three classes of therapeutic agents and are refractory to the last line
of treatment. Potential study participants must have documented evidence of refractory or
progressive disease during or within 60 days (measured from the end of the last cycle) of
completing treatment with the last anti-myeloma drug regimen used just prior to study
entry. Study participants will receive SC administration of elranatamab until disease
progression, unacceptable toxicity or death. The primary short term outcome is
hospitalization rate within the first 2 weeks of Cycle 1 of treatment; the primary long
term outcome is rate of grade 3+ infections within the first 24 months of treatment.
Study participants will be followed for survival for 36 months from the date of
enrollment. A total of 40 study participants will be enrolled across approximately 5
Canadian clinical trial sites.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Relapsed and/or refractory MM defined as:
1. Documented evidence of progressive disease (PD) after achieving at least
minimal response (MR) for ≥ 1 cycle during a previous MM treatment (i.e.,
relapsed MM).
2. Disease progression during or within 60 days from the end of the most recent MM
treatment (i.e., refractory MM).
2. Measurable disease based on IMWG criteria, defined as at least one of the following,
documented within 28 days before enrollment:
1. Serum M-protein ≥ 0.5 g/dl.
2. Urine M-protein excretion ≥ 200 mg/24 h.
3. Serum-free light chains (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l)
AND an abnormal serum-free light chain ratio (< 0.26 or > 1.65) only for
patients without measurable serum or urine M protein.
3. Receipt of at least three prior classes of drugs either in separate regimens or as
combinations.
The three classes are defined as:
An immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhibitor
(bortezomib, ixazomib, carfilzomib), and an anti-CD38 drug (daratumumab or
isatuximab).
4. At least 18 years of age.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
Exclusion Criteria:
Medical conditions
1. Active plasma cell leukemia (either 20% of peripheral white blood cells or > 2.0 ×
109/L circulating plasma cells by standard differential).
2. Amyloidosis.
3. POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma cell
disorder, Skin Changes).
4. Monoclonal gammopathy of unknown significance or smoldering multiple myeloma.
5. Solitary plasmacytoma.
6. Stem cell transplant within 12 weeks prior to enrollment or active graft versus host
disease.
7. History of prior treatment with a BCMA targeting agent.
Laboratory Parameters
8. Laboratory results within 28 days as per below prior to enrollment:
- Absolute neutrophil count (ANC) ≤ 1.0 x 109 /L) (use of growth factor is
permitted if completed at least 7 days prior to enrollment).
- Platelet count ≤ 25 x 109 /L (transfusion support permitted if completed at
least 7 days prior to enrollment).
- Hemoglobin ≤ 8.0 g/dL (transfusion support permitted if completed at least 7
days prior to enrollment, concurrent erythropoietin stimulating agents
allowed).
- Serum AST and ALT > 2.5 x upper limit of normal (ULN).
- Creatinine clearance < 30 mL/min (according to the Cockcroft Gault formula, by
24-hour urine collection for creatinine clearance, or according to local
institutional standard method).
- Total bilirubin > 2.0 x ULN (≥ 3.0 unless known to have Gilbert's disease).
Support Requirement
9. As this protocol requires outpatient administration, the patient will be excluded if
they cannot agree to the following for the first 9 days post-first dose of drug
administration:
1. Staying within 60 minutes of travel distance to their trial-based hospital.
2. Must have a caregiver/support person who will stay with the patient.
3. Patient and/or their caregiver/support person agree to monitor and record oral
temperature q8 hours.
4. Patients must agree that if they have an oral temperature of (≥38°C), they must
report to the study team within 1 hour and can come to the hospital for
admission within 2 hours.
Other co-morbidities
10. Impaired cardiovascular function or clinically significant cardiovascular diseases,
defined as any of the following within 6 months before enrollment:
- Acute myocardial infarction or acute coronary syndromes (eg, unstable angina,
coronary artery bypass graft, coronary angioplasty or stenting, symptomatic
pericardial effusion).
- Clinically significant cardiac arrhythmias (eg, uncontrolled atrial
fibrillation or uncontrolled paroxysmal supraventricular tachycardia).
- Thromboembolic or cerebrovascular events (eg, transient ischemic attack,
cerebrovascular accident, deep vein thrombosis [unless associated with a
central venous access complication], or pulmonary embolism).
- Prolonged QT syndrome (or triplicate average QTcF >470 msec at screening).
11. Ongoing Grade ≥2 peripheral sensory or motor neuropathy.
12. History of Guillain-Barre Syndrome (GBS) or GBS variants, or history of any Grade ≥3
peripheral motor polyneuropathy.
13. Unresolved acute effects of any prior therapy for MM in the last three months to
either baseline severity or NCI CTCAE ≤Grade 1.
14. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or
viral infection.
15. Any other active malignancy within 2 years prior to enrollment, except for
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
16. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other
conditions (including lab abnormalities), or surgical (major surgery within 14 days
prior to enrollment) that could interfere with the patient's safety, obtaining
informed consent or compliance to the study procedures.
17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to elranatamab or any of the components of the study treatment.
Concomitant Medications
18. Treatment with a chemotherapeutic or anti-MM drug within the last 28 days or 5
half-lives (whichever is shorter) prior to enrollment or are currently enrolled in
another interventional clinical study.
19. Receipt of any other therapy to treat cancer (including radiation, biologics,
cellular therapies, and/or steroids at doses > 20 mg dexamethasone or equivalent)
within 14 days prior to the enrollment.
20. Receipt of any live vaccine within 30 days prior to enrollment or expected need of
live vaccination during study participation. (Administration of locally approved
non-live vaccine can be done as per local guidelines during the screening and/or
treatment period including the COVID-19 mRNA vaccine. Elranatamab should be
administered ± 7 days from the SARS-CoV-2 vaccine administration).
Pregnancy and Contraception
21. Pregnancy or lactating female or inability of female patients of childbearing
potential (FCBP) to meet contraception requirements (see Section 5.1.3.).
Informed Consent
22. Inability to provide signed, informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arnie Charbonneau Cancer Institute
Address:
City:
Calgary
Zip:
T2N 4Z6
Country:
Canada
Contact:
Last name:
Nazir Jacques Bahlis, MD
Phone:
403-944-1880
Email:
nbahlis@ucalgary.ca
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Contact:
Last name:
Irwindeep Sandhu, MD
Phone:
780-432-8757
Email:
irwindee@ualberta.ca
Facility:
Name:
Vancouver Cancer Center
Address:
City:
Vancouver
Zip:
V5Z 1L3
Country:
Canada
Contact:
Last name:
Christopher Venner, MD
Phone:
604-877-6000
Facility:
Name:
Juravinski Cancer Center
Address:
City:
Hamilton
Zip:
L8V 1C3
Country:
Canada
Contact:
Last name:
Hira Mian, MD
Phone:
905-387-9495
Email:
hira.mian@medportal.ca
Facility:
Name:
Ottawa Hospital
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Contact:
Last name:
Arleigh Robertson McCurdy, MD
Phone:
613-737-8899
Phone ext:
71281
Start date:
November 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Ontario Clinical Oncology Group (OCOG)
Agency class:
Other
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Source:
Ontario Clinical Oncology Group (OCOG)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06421675
