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Proteasome Inhibitor

Isatuximab + Carfilzomib for Multiple Myeloma

Phase 1

Waitlist Available

Research Sponsored by Thomas Martin, MD

Eligibility Criteria Checklist

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

Must have

Diagnosis of multiple myeloma (MM) and documentation of treatment

For patients with platelets > 100,000 cells/ul, able to take aspirin daily as prophylactic anticoagulation therapy for ARM 2

Must not have

History of significant cardiovascular disease, myocardial infarction in the past 6 months, or poorly controlled hypertension

Neuropathy >= grade 3 or painful neuropathy >= grade 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 1, 2, and 3 years from start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing isatuximab given with carfilzomib, with or without dexamethasone and lenalidomide, to see what effects, good and bad, it has in treating patients with multiple myeloma that has come back or did not respond to previous treatment.

Who is the study for?

This trial is for adults with multiple myeloma that has come back or hasn't responded to treatment. They should have had at least one but no more than three prior treatments and can't be very sick (ECOG <=2). People who've had certain other cancers, serious heart issues, or major procedures recently can't join. Participants need to understand the study and agree to use birth control if needed.

What is being tested?

The trial tests a combination of drugs: Isatuximab (a monoclonal antibody), Carfilzomib (blocks cancer cell growth), Dexamethasone, and Lenalidomide (chemotherapy drugs). It aims to find the best dose of Isatuximab with these drugs in patients whose multiple myeloma has returned or is resistant.

What are the potential side effects?

Possible side effects include immune system changes leading to organ inflammation, reactions during infusion into the body, increased risk of infections due to lowered immunity, potential blood disorders from chemotherapy agents like Dexamethasone and Lenalidomide.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with multiple myeloma and have records of my treatment.

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My platelet count is over 100,000 and I can take daily aspirin.

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I am mostly self-sufficient and can carry out daily activities.

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My multiple myeloma has worsened or not responded to my last treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had serious heart issues or a heart attack in the last 6 months, or my high blood pressure is not well controlled.

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I do not have severe or painful nerve damage.

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I had a stem cell transplant less than 12 weeks ago.

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I am currently being treated for an active infection.

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I have no stomach or intestine problems.

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I have had significant bleeding inside my body.

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I have HIV or active hepatitis B or C.

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I take more than 10 mg of prednisone or its equivalent daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 1, 2, and 3 years from start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 1, 2, and 3 years from start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 1, 2, and 3 years from start of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

ARM I: Incidence of Dose-Limiting Toxicities (DLT)

ARM I: Maximum tolerated dose (MTD) of isatuximab

ARM II: Overall Response Rate (ORR)

Secondary study objectives

ARM I: Clinical benefit response (CBR)

ARM I: Incidence of isatuximab-specific antidrug antibodies (ADA)

ARM I: Overall Response Rate (ORR)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (40 mg dexamethasone, isatuximab, carfilzomib)Experimental Treatment3 Interventions

40 mg dexamethasone IV given on Days 1, 8, 15 and 22 (use as premed to isatuximab). All patients will receive a fixed dose of Isatuximab (SAR650984) according to the assigned dose. Patients receive isatuximab IV over 4-6 hours on day 1, 3-4 hours on Day 8, 15, and 22 of cycle 1 and then on days 1 and 15 of subsequent cycle (patients may be eligible for rapid siatuximab given over 75 minutes), and carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (20 mg dexamethasone, isatuximab, carfilzomib)Experimental Treatment3 Interventions

20 mg dexamethasone IV given on days 1, 8, 15, 22 (pre- SAR650984 and carfilzomib), then dexamethasone 4 IV or PO mg Day 2, 9, 16. All patients will receive a fixed dose of Isatuximab (SAR650984) according to their assigned dose cohort. Patients receive isatuximab IV over 4-6 hours on days 1 and 15 of every cycle for the starting cohort, and days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of subsequent cycles. Carfilzomib IV will be administered over 10 minutes on days 1, 2, 8, 9, 15, and 16 . Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may continue treatment after 8 courses if clinical benefit is present at the investigator's discretion (carfilzomib may be switched to days 1, 2, 15, and 16 after 8 cycles per investigator discretion).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isatuximab

2016

Completed Phase 3

~370

Carfilzomib

2017

Completed Phase 3

~1430