What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bortezomib, lenalidomide, dexamethasone, carfilzomib, and pomalidomide, are associated with a range of side effects. Bortezomib can cause peripheral neuropathy, gastrointestinal distress, and cytopenias. Lenalidomide and pomalidomide often lead to hematologic toxicities like thrombocytopenia and neutropenia, as well as gastrointestinal issues such as diarrhea and constipation. Dexamethasone is known for causing hyperglycemia, insomnia, and increased infection risk. Carfilzomib may result in cardiovascular events, renal toxicity, and fatigue. These side effects are important considerations when managing treatment plans for Multiple Myeloma patients.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, often used in combination regimens. Notable approvals include bortezomib, lenalidomide, and dexamethasone, which are frequently used together or with other agents like cyclophosphamide. Daratumumab, a monoclonal antibody, has been approved in combination with lenalidomide and dexamethasone, as well as with pomalidomide and dexamethasone for relapsed or refractory cases. Carfilzomib, another proteasome inhibitor, is also approved in combination with dexamethasone and daratumumab. These treatments aim to target and inhibit the growth of myeloma cells, similar to the investigational drug ORIC-533.

What other types of research exist?

Promising novel alternatives to ORIC-533 for Multiple Myeloma patients include: <ol> <li>Venetoclax – A BCL2 inhibitor showing efficacy in combination therapies for relapsed and refractory Multiple Myeloma.</li> <li></li> </ol> Selinexor – An oral selective inhibitor of nuclear export, approved for use in combination with other agents for Multiple Myeloma. 3. Belantamab mafodotin – An antibody-drug conjugate targeting BCMA, showing promise in clinical trials for relapsed/refractory Multiple Myeloma. 4. CAR T-cell therapies (e.g., idecabtagene vicleucel) – Personalized immunotherapies targeting BCMA, demonstrating significant efficacy in advanced Multiple Myeloma.

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Small Molecule Inhibitor

ORIC-533 for Multiple Myeloma

Phase 1

Waitlist Available

Research Sponsored by ORIC Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

ECOG performance status ≤2

Refractory to or not eligible for MM treatment regimens known to provide clinical benefit, including but not limited to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, with documented disease progression

Must not have

Known central nervous system (CNS) involvement

Infection requiring systemic antibiotic therapy or other serious infection within 14 days of starting therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ORIC-533, a new oral drug, on patients with multiple myeloma who have no other treatment options. The drug works by blocking a protein called CD73, which may help stop cancer cells from growing.

Who is the study for?

This trial is for adults with multiple myeloma that's come back or hasn't responded to treatment. They should have tried treatments like immunomodulators, proteasome inhibitors, and anti-CD38 antibodies without success. Participants need good heart, lung, liver, kidney function and a certain level of blood cells. People can't join if they've had major surgery recently, other cancers in the last 3 years (with some exceptions), severe heart issues in the past 6 months, active infections or certain chronic conditions.

What is being tested?

The study tests ORIC-533 on patients whose multiple myeloma has relapsed or is refractory after standard treatments failed. It aims to find out the safest dose that works (RP2D), how it affects the body (PK/PD), and its effectiveness against cancer cells.

What are the potential side effects?

While specific side effects of ORIC-533 are not listed here, common ones for new cancer drugs may include nausea, fatigue, risk of infection due to low blood cell counts, liver problems indicated by changes in enzyme levels and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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

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My multiple myeloma has not responded to standard treatments, including immunotherapy, proteasome inhibitors, and anti-CD38.

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My multiple myeloma has come back or is not responding to treatment.

Exclusion Criteria

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

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My cancer has spread to my brain or spinal cord.

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I have not needed antibiotics for a serious infection in the last 14 days.

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I have had or currently have plasma cell leukemia, AL amyloidosis, or POEMS syndrome.

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I haven't had severe heart issues or a heart attack in the last 6 months.

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I haven't had major surgery or radiation within the last 2 weeks.

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I take more than 10 mg/day of corticosteroids, not including inhalers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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

Number of participants with abnormal laboratory

Number of participants with adverse events

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

Area under the curve last concentration (AUClast)

Elimination half-life (t1/2)

Maximum plasma concentration (Cmax)

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: Dose ExpansionExperimental Treatment1 Intervention

RP2D dose

Group II: Dose EscalationExperimental Treatment1 Intervention

ORIC-533 dosed orally, once per day of each consecutive 28-day cycle.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments primarily include proteasome inhibitors (e.g., bortezomib, carfilzomib), immunomodulatory drugs (e.g., lenalidomide, pomalidomide), and monoclonal antibodies (e.g., daratumumab, isatuximab). Proteasome inhibitors disrupt protein degradation, leading to cancer cell death. Immunomodulatory drugs enhance the immune response against myeloma cells and inhibit their growth. Monoclonal antibodies target specific proteins on myeloma cells, marking them for destruction by the immune system. Investigational drugs like ORIC-533 aim to provide new mechanisms to combat resistant myeloma. These treatments are crucial as they offer multiple pathways to control the disease, improve survival rates, and enhance the quality of life for patients.

Emerging therapies for multiple myeloma.