Trial Title:
Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes
NCT ID:
NCT06282978
Condition:
Multiple Myeloma in Relapse
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Relapsed Refractory Multiple Myeloma
Elranatamab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is an open label, multicenter, phase II study of Elranatamab as single agent. The
primary aiming is to evaluate the efficacy of elranatamab monotherapy in participants
with relapsed refractory multiple myeloma (RRMM) who had received prior treatment with
immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to
the last line of therapy as evaluated with the rate of complete Response and Undetectable
Measurable Residual Disease. Efficacy refers to the rate of Undetectable Measurable
Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG)
criteria evaluated by the investigators.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Elranatamab (PF-06863135)
Description:
The scheme of administration includes weekly administrations for at least six 4-weeks
cycles and, if patients have achieved at least PR (or better) persisting for at least 2
months, the dose interval should be changed from weekly to every other week. Treatment
will be scheduled with a response-adapted duration and patients achieving undetectable
measurable residual disease (MRD) and maintained for 12 months will stop therapy. After
stopping therapy, and if the patient is in sustained undetectable MRD for at least 12
months, it would be possible to re-start treatment with elranatamab in case the MRD will
be detectable or relapse from CR will occur. Patients who will not achieve undetectable
MRD sustained for 12 months will receive continuous treatment until progressive disease.
Arm group label:
Elranatamab
Summary:
The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i)
the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg
subcutaneously in participants with RRMM after at least one or two prior lines of therapy
who have received prior treatment with immunomodulatory drugs, protease inhibitors, and
anti-CD38 therapy and were refractory to the last line of therapy, defined as progression
while receiving treatment or in the first 60 days after the last dose of treatment.
Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12
months as per International Myeloma Working Group (IMWG) criteria evaluated by the
investigators.
Safety refers to the measurement of:
i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical
and laboratory tests (hematology and chemistry, physical examination, vital sign
measurements, and diagnostic tests).
ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell
associated neurotoxicity syndrome (ICANS) according to the American Society for
Transplantation and Cellular Therapy (ASTCT) criteria.
iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and
infections
The study consists of a screening/baseline period, a treatment period, and a
posttreatment follow-up period. The study includes a periodic review of safety data, that
will be independently analyzed by the Data Safety Independent Committee (DSMC) and will
recommend how to proceed with the study.
Detailed description:
Treatment with elranatamab will be initiated using a 2-step-up priming regimen: the
initial doses of elranatamab will be 12 mg (Cycle 1 Day 1) and 32 mg (Cycle1 Day 4).
Participants should be hospitalized and monitored for toxicity (especially CRS/ICANS) for
at least 2 days (~48 hours) beginning on Cycle 1 Day 1, and for 1 day (~24 hours) for
Cycle1 Day 4. The dose of elranatamab should be increased to 76 mg on Cycle 1 Day 8 as
long as the participant meets the redosing criteria or deferred until the criteria are
met.
The scheme of administration includes weekly administrations for at least six 4-weeks
cycles and, if patients have achieved at least PR (or better) persisting for at least 2
months, the dose interval should be changed from weekly to every other week. Treatment
will be scheduled with a response-adapted duration and patients achieving undetectable
measurable residual disease and maintained for 12 months will stop therapy. After
stopping therapy, and if the patient is in sustained undetectable measurable residual
disease for at least 12 months, it would be possible to re-start treatment with
elranatamab in case the measurable residual disease will be detectable or relapse from CR
will occur. Patients who will not achieve undetectable measurable residual disease
sustained for 12 months will receive continuous treatment until progressive disease. In
both situations, the occurrence of unacceptable toxicity might result into the treatment
discontinuation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female, 18 years or older (at the time consent is obtained).
- Patient who, in the investigator's opinion, is able to comply with the protocol
requirements.
- Prior diagnosis of MM as defined according to IMWG criteria.
- Patient has given voluntary written informed consent before performance of any
study-related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the patient at any time without prejudice to their
future medical care.
- Relapse multiple myeloma patients that have received at least 1 or 2 prior lines of
therapy including at least to one proteasome inhibitor (bortezomib, carfilzomib or
ixazomib), one immunomodulatory drug (lenalidomide is mandatory and patients can be
also have been exposed to pomalidomide) and at least one anti-CD38 monoclonal
antibody (daratumumab or isatuximab).
- Patients must be refractory to the last line of therapy, defined as progression
while receiving treatment or in the first 60 days after the last dose of treatment.
- Patient must have a measurable secretory disease defined as either serum monoclonal
protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200 mg/24 h. For
patients in whom disease is only measurable by serum FLC, the involved FLC should be
≥ 10mg/dL (100 mg/L), with an abnormal serum FLC ratio.
Exclusion Criteria:
- Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of
undetermined significance (MGUS), smoldering multiple myeloma (SMM), POEMS syndrome
(defined by the presence of peripheral neuropathy, organomegaly, endocrinopathy,
monoclonal plasma-cells proliferative disorder, and skin changes) or plasma cell
leukemia.
- Prior anti-BCMA treatment.
- Subject has peripheral neuropathy or neuropathic pain grade 2 or higher, as defined
by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE)
Version 5.
- History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3
peripheral motor polyneuropathy.
- Stem cell transplant within 12 weeks prior to enrolment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Clínico Universitario de Santiago ~ CHUS
Address:
City:
Santiago De Compostela
Zip:
15706
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Marta Sonia Gonzalez Perez, MD
Investigator:
Last name:
Marta Sonia Gonzalez Perez, MD
Email:
Principal Investigator
Facility:
Name:
Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Albert Oriol Rocafiguera, MD
Investigator:
Last name:
Albert Oriol Rocafiguera, MD
Email:
Principal Investigator
Facility:
Name:
Institut Catala d'Oncologia (ICO) Hospital Duran i Reynals
Address:
City:
L'Hospitalet De Llobregat
Zip:
08908
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Ana Sureda, MD
Investigator:
Last name:
Ana Sureda, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Marqués de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Enrique M Ocio San Miguel, MD
Investigator:
Last name:
Enrique M Ocio San Miguel, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario de Jerez de la Frontera
Address:
City:
Jerez De La Frontera
Zip:
11407
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Sebastian Garzon Lopez, MD
Investigator:
Last name:
Sebastian Garzon Lopez, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Son Llàtzer
Address:
City:
Palma De Mallorca
Zip:
07198
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Joan LL Bargay, MD
Investigator:
Last name:
Joan LL Bargay, MD
Email:
Principal Investigator
Facility:
Name:
CHU de Gran Canaria Doctor Negrín
Address:
City:
Las Palmas De Gran Canaria
Zip:
35010
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Alexia T Suarez Cabrera, MD
Investigator:
Last name:
Alexia T Suarez Cabrera, MD
Email:
Principal Investigator
Facility:
Name:
Hospital HM Sanchinarro
Address:
City:
Sanchinarro
Zip:
28050
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Jaime Perez de Oteysa, MD
Investigator:
Last name:
Jaime Perez de Oteysa, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Clínico Universitario Virgen de la Arrixaca
Address:
City:
El Palmar
Zip:
30120
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Begoña Navarro de Almenzar, MD
Investigator:
Last name:
Begoña Navarro de Almenzar, MD
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad Navarra (CUN)
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Jesus San Miguel Izquierdo, MD
Phone:
+34 948 296 296
Email:
sanmiguel@unav.es
Investigator:
Last name:
Paula Rodriguez Otero, MD
Email:
Principal Investigator
Facility:
Name:
H. Clínic i Provincial de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Joan Bladé, MD
Phone:
+34 932275428
Email:
jblade@clinic.cat
Investigator:
Last name:
Laura Rossiñol, MD
Email:
Principal Investigator
Facility:
Name:
Hospital de Cabueñes
Address:
City:
Gijón
Zip:
33394
Country:
Spain
Status:
Recruiting
Contact:
Last name:
María Esther González García, MD
Phone:
+ 34 985 18 50 00
Investigator:
Last name:
María Esther González García, MD
Email:
Principal Investigator
Facility:
Name:
Instituto de Investigación Sanitaria Hospital 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Juan Jose Lahuerta, MD
Phone:
+34 91 779 28 39
Email:
jjlahuerta@telefonica.net
Facility:
Name:
Hospital Clínico Universitario Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Mª Victoria Mateos, MD
Phone:
+34 923 291 100
Phone ext:
55384
Email:
mvmateos@usal.es
Contact backup:
Last name:
Verónica González de la Calle, MD
Phone:
+34 923 291 100
Phone ext:
55629
Email:
vgcalle@saludcastillayleon.es
Investigator:
Last name:
Mª Victoria Mateos, MD
Email:
Principal Investigator
Facility:
Name:
C.H. de Toledo (Virgen de la Salud)
Address:
City:
Toledo
Zip:
45005
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Luis Felipe Casado Montero, MD
Investigator:
Last name:
Luis Felipe Casado Montero, MD
Email:
Principal Investigator
Start date:
November 23, 2023
Completion date:
December 2029
Lead sponsor:
Agency:
PETHEMA Foundation
Agency class:
Other
Source:
PETHEMA Foundation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06282978
