This study has been transitioned to CTIS with ID 2023-508897-27-00 check the CTIS register for the current data. Primary:• To compare the efficacy of elranatamab vs lenalidomide Secondary:- To compare the efficacy of elranatamab vs lenalidomide- To…
ID
Source
Brief title
Condition
- White blood cell disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• PFS by BICR per IMWG
Secondary outcome
• OS
• MRD negativity rate at 12 months after randomization per IMWG as assessed via
NGS PFS by investigator per IMWG
• Sustained MRD negativity rate at 24 months after randomization as
assessed via NGS
• PFS by investigator per IMWG
• Overall MRD negativity rate per IMWG
• Duration of MRD negativity per IMWG
• Sustained MRD negativity per IMWG
• CRR by BICR and investigator per IMWG
• DOCR by BICR and investigator per IMWG
• PFS2 by Investigator per IMWG
• AEs and laboratory abnormalities as graded by NCI CTCAE v5.0.
• Severity of CRS and ICANS assessed according to ASTCT criteria
• Pre- and postdose concentrations of elranatamab
• ADAs and Nabs against elranatamab
• EORTC QLQ-C30 and MY20
Background summary
Multiple myeloma is a blood cancer and is characterized by typical
manifestations of organ damage such as bone lesions, increased calcium level in
blood, low number of red blood cells and kidney damage. Despite recent advances
in treatment, multiple myeloma remains an incurable disease and almost all
patients, even those who initially respond to treatment, are expected to
relapse.
Elranatamab is a type of antibody drug. Antibodies are a part of the immune
system. Elranatamab binds to T-cells (a type of immune system cell) and myeloma
cells; this causes the T-cells to kill the myeloma cells. Elranatamab is
considered investigational drug because it is not approved for use in the
Netherlands.
Lenalidomide is a drug that changes the immune response, and targets and kills
myeloma cells. It helps your immune system recognize and destroy myeloma cells
and prevents new myeloma cell growth by starving them of blood. Lenalidomide
was selected as the comparator drug in this study as it is considered the
standard of care therapy and the only approved maintenance therapy following an
ASCT.
Study objective
This study has been transitioned to CTIS with ID 2023-508897-27-00 check the CTIS register for the current data.
Primary:
• To compare the efficacy of elranatamab vs lenalidomide
Secondary:
- To compare the efficacy of elranatamab vs lenalidomide
- To determine the safety and tolerability of elranatamab
- To evaluate the PK of elranatamab
- To evaluate the immunogenicity of elranatamab
- To evaluate the impact of study intervention on participant health-related
quality of life (HRQoL)
Tertiary/Exploratory:
- To explore the relationship between elranatamab and the biology of the
participant*s MM
- To explore correlations between elranatamab exposure and efficacy, safety and
biomarker endpoints, if data allow
- To assess the impact of study intervention on patient-reported symptoms and
functioning
- To collect healthcare resource use data
Study design
Study C1071007 is a Phase 3, open-label, randomized, 2-arm study of elranatamab
monotherapy vs lenalidomide in participants with newly diagnosed multiple
myeloma after undergoing ASCT.
Intervention
Arm A: The people in this group will get elranatamab
Arm B: The people in this group will get lenalidomide
Arm C: The people in this group will get elranatamab
Study burden and risks
The subjects participation may help future patients by increasing our
understanding of elranatamab in treating multiple myeloma. It is possible that
their condition or health may improve, worsen, or stay the same.
The subject may experience the side effects or adverse effects of the study
drug, as described in Section 6 of the main ICD. There may be some discomfort
from the measurements during the study. Taking part in the study will cost the
subject extra time, and he/she will need to be hospitalized.
Based on data from the ongoing Phase 1 study, elranatamab monotherapy has
demonstrated the potential to convert heavily pretreated patients with
relapsed/refractory multiple myeloma to MRD-negative status. Therefore, and
consequently it is expected to provide clinical benefit including the potential
for a prolonged progression-free disease to participants with newly diagnosed
multiple myeloma with MRD-positive status after undergoing ASCT with an
acceptable and manageable safety profile. All participants will benefit from
close monitoring that go beyond the SOC in the maintenance setting.
Taking into account the measures taken to minimize risk to study participants,
the potential risks identified with elranatamab are justified by the
anticipated benefits that may be afforded to participants with newly diagnosed
multiple myeloma who are MRD-positive after undergoing ASCT.
Rivium Westlaan 142
Capelle a/d IJssel 2909LD
NL
Rivium Westlaan 142
Capelle a/d IJssel 2909LD
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) - with
measurable disease at diagnosis as defined by serum M protein >=0.5 g/dL (5
g/L), by urine M protein >=200 mg/24 hours, or by serum FLC assay with involved
FLC level >=10 mg/dL, provided serum FLC
ratio is abnormal.
History of induction therapy and autologous stem cell transplant.
Randomization must occur within 120 days from the stem cell
transplant. For participants who receive consolidation therapy after
ASCT, randomization must occur within 60 days of consolidation and
within 7 months from ASCT. Screening tests should be performed after the last
dose of consolidation.
- Partial Response or better according to IMWG criteria at the time of
randomization
- Identification of the dominant malignant (index) clone as assessed by central
laboratory NGS test (Adaptive Biotechnologies clonoSEQ® assay or as described
in Appendix 10.9.6).
- Must have an archival bone marrow aspirate sample(s) that identified
the dominant malignant (index) clone that is used to track MRD status.
This sample should preferably be collected before induction treatment (eg, at
diagnosis) or before transplant.
- A bone marrow aspirate sample collected at screening is required to determine
MRD status
-ECOG performance status <= 1
- Resolved acute effects of any prior therapy to baseline severity or
CTCAE Grade <= 1
- Not pregnant and willing to use contraception
Exclusion criteria
- Plasma cell leukemia
- Amyloidosis, Waldenström's macroglobulinemia, or POEMS syndrome
- Known active CNS involvement or clinical signs of myelomatous meningeal
involvement.
- Previous MM maintenance treatment
- Prior treatment with BCMA targeted therapy
- Any other active malignancy within 3 years prior to enrolment, except for
adequately treated basal cell or squamous cell skin cancer, or carcinoma in
situ or Stage 0/1 with minimal risk of recurrence per the investigator.
- Active, uncontrolled bacterial, fungal, or viral infection, including (but
not limited to) HBV, HCV, and known HIV or AIDS-related illness. Active
Infection must be resolved at least 21 days prior to enrollment. Patients
treated with systemic anti-infectious agents within 28 days prior to enrollment
are not eligible. Prophylactic use of systemic agents is permitted.
- Previous administration with an investigational drug or vaccine within 30
days (or as determined by the local requirement) or 5 half lives preceding the
first dose of study intervention used in this study
(whichever is longer)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-508897-27-00 |
| EudraCT | EUCTR2021-006052-14-NL |
| ClinicalTrials.gov | NCT05317416 |
| CCMO | NL80153.056.22 |