Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
ConditionAL Amyloidosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Previously diagnosed with AL amyloidosis based on IMWG criteria who have relapsed or refractory disease after treatment with at least one prior line of therapy (minimum 2 cycles).
Participants must have progression of light chain disease, defined as dFLC >20mg/L.
For Phase 2 only, measurable hematologic disease, satisfying one of the following criteria: Difference between involved and uninvolved free light chain (FLC) over 40 mg/L; Abnormal level of FLC with an abnormal κ/λ ratio (except in participants with CKD stage 3 or higher where a rise of lambda FLC to an abnormal level and of at least 50% over the nadir with a normal κ/λ ratio is acceptable); A serum M spike measuring ≥ 0.5 g/dL
Age ≥ 18 years
Disqualifiers
Prior BCMA-targeting bispecific antibodies or BCMA-targeting CAR-T therapy.
Participants refractory to belantamab mafodotin OR participants that have received belantamab as the immediate past line of therapy.
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
Participants who are receiving any other investigational agents for this condition.
Trial design
Design model
Single group
Treatments tested in this trial
Elranatamab
DrugElranatamab administered subcutaneously for 6 cycles of treatment with 28 days in a treatment cycle
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: Elranatamab Dose ScheduleExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To determine RP2D
The recommended phase 2 dose determined in phase 1
Time frame
up to 26 months2
To evaluate objective response rate (ORR)
Defined as the proportion of patients with CR, VGPR, or PR, and will be provided as unconfirmed and confirmed ORR at the end of six cycles of treatment. Confirmed responses are those that persist on repeat imaging study at least 28 days after the initial documentation of response.
Time frame
up to 60 monthsSecondary outcomes
1
To assess safety and tolerability of elranatamab in patients with relapse or refractory AL amyloidosis
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Time frame
up to 72 months2
To assess best overall response (BOR)
BOR will be analyzed as the number of patients (percentage) with each response, divided by the number of patients treated.
Time frame
up to 72 months3
To assess duration of response (DoR)
DoR will be analyzed using Kaplan-Meier method and is defined as the time from the first documentation of CR, VGPR, or PR to the first documentation of objective progression or death due to any cause. .
Time frame
up to 72 months4
To assess progression-free survival (PFS)
Progression-free Survival (PFS) will be analyzed using Kaplan-Meier method and is defined as the time from Cycle 1 Day 1 to first documentation of objective progression (PD) or death due to any cause, whichever comes first.
Time frame
up to 72 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov