Elotuzumab for Myelofibrosis

Recruiting in Palo Alto (17 mi)

Overseen by Prithviraj Bose

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

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial investigates how well elotuzumab works in treating patients with JAK2-mutated myelofibrosis. Elotuzumab may help to control myelofibrosis and/or help to improve blood cell count and bone marrow function.

Eligibility Criteria

Adults with JAK2 V617F+ myelofibrosis needing treatment and at intermediate/high risk. They must have good performance status, specific blood counts, liver and kidney function levels, agree to use contraception, and not be candidates for JAK inhibitor therapy. Excluded are those recently on certain treatments or with allergies to similar drugs, CNS involvement, uncontrolled illnesses, pregnancy/lactation, HIV/HBV/HCV positivity or prior transplants.

Inclusion Criteria

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 6 months after the last administration of elotuzumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of child-bearing potential must have a negative pregnancy test. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after the last administration of elotuzumab

I have a type of blood cancer called myelofibrosis with a specific mutation and it's considered intermediate or high risk.

My bone marrow fibrosis is moderate to severe.

Exclusion Criteria

I have not had radiation to my spleen in the last 4 months.

My cancer has spread to my brain or spinal cord.

I haven't taken any experimental drugs recently.

Participant Groups

The trial is testing Elotuzumab's effectiveness in treating patients with JAK2-mutated myelofibrosis to control the disease and improve blood cell count and bone marrow function. It also includes questionnaire administration to gather patient-reported outcomes.

Group I: Treatment (elotuzumab) Experimental Treatment 2 Interventions

Patients receive elotuzumab IV over 1-4 hours on days 1, 8, 15, and 22 of cycles 1-2. Beginning in cycle 3, patients receive elotuzumab IV over 1-4 hours on day 1. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as Empliciti for:

• Multiple myeloma

🇪🇺 Approved in European Union as Empliciti for:

• Multiple myeloma

🇨🇦 Approved in Canada as Empliciti for:

• Multiple myeloma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

References