SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

About this trial

This phase I trial tests the safety and side effects of SX-682 in combination with standard of care treatment carfilzomib, daratumumab-hyaluronidase, and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). SX-682 works by blocking certain sites on cells that suppress the ability of the immune system to destroy tumor cells. Blocking those specific sites allows other cells of the immune system to become "free" to kill tumor cells. Carfilzomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and tumor cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill tumor cells, while hyaluronidase helps to deliver daratumumab to CD38-expressing tumor cells through a subcutaneous injection. Dexamethasone is in a class of medications called corticosteroids. It is known to kill myeloma cells and is also used to reduce inflammation and lower the body's immune response to monoclonal antibodies like dratumumab and help lessen its side effects. Giving SX-682 in combination with carfilzomib, daratumumab-hyaluronidase and dexamethasone may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed relapsed/ refractory multiple myeloma

Serum M-protein ≥ 0.5 g/dL

Urine M-protein ≥ 200 mg/24h

Serum free light chain assay: involved free light chain (FLC) level greater or equal to 100 mg/L provided serum free light chain ratio is abnormal

Disqualifiers

Patients with non-secretory myeloma, systemic light chain amyloidosis or, plasmacytoma

Intolerance to SX-682 or any other of the treatment components

Refractory to prior carfilzomib (i.e. relapse or progression on or within 60 days after completion of treatment)

Refractory to prior daratumumab (i.e. relapse or progression on or within 60 days after completion of treatment)

Trial design

Design model

Single group

Treatments tested in this trial

  • Cxcr1/2 Inhibitor SX-682

    Drug

    Given PO

  • Daratumumab and Recombinant Human Hyaluronidase

    Drug

    Given SC

  • Carfilzomib

    Drug

    Given IV

  • Dexamethasone

    Drug

    Given PO

  • Biospecimen Collection

    Procedure/Surgery

    Undergo Blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo Bone Marrow Aspiration

  • Echocardiography

    Procedure/Surgery

    Undergo ECHO

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicity

Dose limiting toxicities will be summarized using frequencies and relative frequencies. Estimates of the dose-limiting toxicity rates will be obtained with 90% credible regions obtained by Jeffrey's prior method. The summary will be performed by dose level, if applicable.

Time frame
WIthin the first 28 days of start of treatment

Secondary outcomes

1

Percentage of Overall response rate

Obtained using Jeffrey's prior method

Time frame
Up to 3 years after last patient is enrollled
2

Percentage of Progression-free survival

Determined using Kaplan-Meier estimates

Time frame
Up to 3 years after last patient is enrolled
3

Percentage of Overall Survival

Determined using Kaplan-Meier estimates

Time frame
Up to 3 years after last patient is enrolled
4

Incidence of Adverse Events (AE's_

AE's will be grading using CTCAE v.5.

Time frame
Within the first 6 months of treatment

Other outcomes

Sponsors and contacts

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