Isatuximab for Smoldering Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen bySheeba Thomas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a multi-center, open label, phase II study designed to evaluate the efficacy of isatuximab with or without lenalidomide when given to patients with high risk smoldering multiple myeloma.

Eligibility Criteria

Adults over 18 with high risk smoldering plasma cell myeloma, showing specific levels of monoclonal protein or bone marrow plasma cells. They must be at high risk for developing multiple myeloma and have good kidney, liver, and blood health. Women who can bear children and men with partners who can must use birth control. Exclusions include HIV, recent major surgery, uncontrolled diseases like heart failure or hypertension, prior treatments for this condition, pregnancy or breastfeeding.

Inclusion Criteria

I am at high risk of my condition progressing to multiple myeloma according to PETHEMA criteria.

I am 18 years old or older.

I am able to get out of my bed or chair and move around.

See 8 more

Exclusion Criteria

I have not undergone radiotherapy.

Your blood calcium levels are too high.

I do not have any uncontrolled illnesses like high blood pressure or heart problems.

See 20 more

Treatment Details

Interventions

Isatuximab (Monoclonal Antibodies)

Trial OverviewThe trial is testing Isatuximab's effectiveness in patients with a pre-cancerous condition called high risk smoldering plasma cell myeloma. It's an immunotherapy that may help the immune system prevent tumor growth and spread. The study includes monitoring through lab biomarker analysis to see how well it works.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (isatuximab)Experimental Treatment2 Interventions

Patients receive isatuximab IV over 5 hours on day 1 of cycle 1, and over 3 hours thereafter on days 8, 15, and 22 of cycle 1, on days 1 and 15 of cycles 2-6, and on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity.

Isatuximab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Sarclisa for:

Multiple myeloma

🇺🇸 Approved in United States as Sarclisa for:

Multiple myeloma in combination with pomalidomide and dexamethasone for adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
Multiple myeloma in combination with carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
Newly diagnosed multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for adults who are not eligible for autologous stem cell transplant