← Back to Search

Monoclonal Antibodies

Elranatamab for AL Amyloidosis

Phase 1 & 2

Recruiting

Led By Giada Bianchi

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Participants must meet the following organ and marrow function as defined below: Absolute leukocyte count ≥3,000/mcL , Absolute neutrophil count ≥1,000/mcL, Absolute platelet count ≥75,000/mcL , Direct bilirubin ≤1.5 × institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN, Creatinine: Calculated clearance ≥30 mL/min using Cockcault-Groft equation

* 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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test how safe and effective elranatamab is for patients with relapsed or refractory AL amyloidosis."

Who is the study for?

This trial is for adults over 18 with AL amyloidosis that has come back or didn't respond to treatment. They should be relatively active (able to care for themselves) and have certain levels of blood cells, liver, and kidney function. People who've had belantamab mafodotin can join if they stopped due to side effects. Those with chronic hepatitis must have it under control.

What is being tested?

The study tests elranatamab's safety and effectiveness in those whose AL amyloidosis hasn't improved after previous treatments. It looks at how well patients tolerate the drug and its impact on their disease, especially for those with specific heart conditions and measurable signs of the disease in their blood.

What are the potential side effects?

While not specified here, common side effects may include reactions at the injection site, fatigue, nausea, low blood cell counts increasing infection risk or bleeding problems, liver issues indicated by changes in enzyme levels, and potential kidney impairment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have AL amyloidosis that didn't respond to at least one prior treatment.

Select...

My light chain levels have increased by more than 20mg/L.

Select...

I am 18 years old or older.

Select...

I had hepatitis C but am cured, or I'm being treated with no detectable virus.

Select...

I can take care of myself but might not be able to do active work.

Select...

My hepatitis B virus load is undetectable with treatment.

Select...

My AL amyloidosis is classified as cardiac stage I, II, or IIIa.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine RP2D

To evaluate objective response rate (ORR)

Secondary study objectives

Incidence and severity of cytokine release syndrome (CRS) and immune effector cell- associated neurotoxicity syndrome (ICANS)

Incidence of treatment emergent adverse events

To assess best overall response (BOR)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Elranatamab Dose ScheduleExperimental Treatment1 Intervention

Phase I: Phase I will enroll up to 20 participants. All participants in Phase I will be hospitalized during Cycle 1 dosing. The first 5 participants will be hospitalized for 9 days, and subsequent participants will be hospitalized for 5 days. Elranatamab will be administered subcutaneously at a dose of 12 mg on C1D1, 32 mg on C1D4, and 76 mg on C1D8. Subsequent treatment doses will be 76 mg thereafter. If two or more participants at Level 0 experience DLT, dose will be decreased to Level -1. If 2 or more participants at Level -1 experience DLT, the trial will be discontinued. Phase II: All participants in Phase 2 will receive the RP2D determined in Phase 1. Phase 2 will enroll an additional 29 participants. If RP2D is determined to be Dose Level 0, the treatment schedule will be the same as described in Dose Level 0. If RP2D is determined to be Dose Level -1, the treatment schedule will be the same as described in Dose Level -1.Treatment duration is 6 cycles of 28 days per cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elranatamab

2023

N/A

~1030

0 / 8Eligibility criteria met