CC-92480 + Dexamethasone for Multiple Myeloma

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Celgene

No Placebo Group

Trial Summary

What is the purpose of this trial?This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM). All eligible subjects must be previously treated with at least 3 prior regimens including lenalidomide, pomalidomide, a proteasome inhibitor and an anti-CD38 antibody and be refractory to their last line of therapy.

Eligibility Criteria

This trial is for adults over 18 with relapsed and refractory multiple myeloma who've had at least 3 prior treatments, including specific medications, and are not responding to their last therapy. They must have measurable disease, meet certain lab value criteria, be able to follow the study plan, and use contraception if of childbearing potential.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I am following the required contraception guidelines.

I am 18 years or older and can sign the consent form.

My condition hasn't improved after taking certain medications.

I have undergone 3 or more treatments for myeloma, including specific medications.

I have been diagnosed with multiple myeloma and it can be measured.

Exclusion Criteria

I have had a bone marrow transplant from another person.

I have moderate to severe nerve damage.

I had major surgery recently.

I have heart problems that affect my daily activities.

I have been diagnosed with amyloidosis or POEMS Syndrome.

I am currently receiving treatment for another type of cancer.

I have an active chronic hepatitis B or C infection.

I have been treated for myeloma with specific drugs recently.

I cannot or do not want to follow the required blood clot prevention treatment.

My multiple myeloma does not produce detectable levels of M protein.

I am HIV positive.

My multiple myeloma has not responded to treatment.

I have IgM myeloma.

I have plasma cell leukemia or active leptomeningeal myelomatosis.

I am currently receiving dialysis.

Treatment Details

The trial is testing CC-92480 alone and combined with Dexamethasone in patients whose multiple myeloma has returned or resisted treatment. It's an open-label Phase 1/2 study assessing safety, how the body processes the drug (PK), and its effectiveness against this cancer.

2Treatment groups

Experimental Treatment

Group I: Administration of CC-92480 monotherapyExperimental Treatment1 Intervention

Escalating doses of CC-92480 Monotherapy administered according to different dosing schedules

Group II: Administration of CC-92480 in combination with dexamethasoneExperimental Treatment2 Interventions

Part 1: Escalating doses of CC-92480 plus a fixed dose of dexamethasone Part 2: RP2D of CC-92480 in combination with dexamethasone