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Recurrent Multiple MyelomaPhase 1NCT06622005

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

A Phase 1 study testing Cxcr1/2 Inhibitor SX-682, Daratumumab and Recombinant Human Hyaluronidase and Carfilzomib in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by Roswell Park Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cxcr1/2 Inhibitor SX-682, Daratumumab and Recombinant Human Hyaluronidase and Carfilzomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
10 Apr 2025to 10 Apr 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed relapsed/ refractory multiple myeloma
  • Measurable disease including at least one of the following criteria:
  • 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
  • Bone marrow plasma cells ≥ 10% total bone marrow cells
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  • ≥ 1 prior line of therapy
  • Planned treatment with a carfilzomib/daratumumab/dexamethasone regimen
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Absolute neutrophil count: ≥ 1.5 x 10^9/L
  • Platelets: ≥ 75 x 10^9/L
  • Hemoglobin: ≥ 7 g/dL
  • Total bilirubin: ≤ 1.5 x upper limit of normal (ULN): ≤ 3.0 x ULN for Gilbert's syndrome
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]): ≤ 3 x ULN
  • Renal Function: Estimated creatinine clearance ≥ 45 mL/min (Cockroft-Gault)
  • Left ventricular ejection fraction of at least 50%
  • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months following the last dose of the investigational drug. 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
  • Participant must understand the investigational nature of this study and sign an Independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure

Who cannot join

  • 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)
  • Concomitant medication(s) known to be (a) a strong inhibitor or inducer of CYP3A4, or (b) QT prolonging as defined in the drug's approved label, with the exception of drugs that are considered absolutely essential for the care of the subject or if the investigator believes that beginning therapy with such medication is vital to an individual subject's care while on study, and in either case, there is no alternative medication
  • Electrocardiogram (ECG) demonstrating a corrected QT (QTc) interval > 470 msec or patients with congenital long QT syndrome
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  • Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina or congestive heart failure in the last 6 months
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, class III or IV heart failure (New York Heart Association functional classification system) or psychiatric illness/social situations that would limit compliance with study requirements
  • History of hepatitis B, C or HIV
  • Known active bacillus tuberculosis infection
  • Pregnant or nursing female participants
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ASK RPCI contact

1-877-275-7724

askrpcil@roswellpark.org

United States1 site, 1 recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

    Recruiting

Other trials in United States

About this study

Official title: Phase 1 Trial of SX-682, a CXCR 1/2 Inhibitor, in Combination With Standard of Care Treatment in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

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

Being tested
Cxcr1/2 Inhibitor SX-682, Daratumumab and Recombinant Human Hyaluronidase, Carfilzomib, Dexamethasone, Biospecimen Collection
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cxcr1/2 Inhibitor SX-682Drug

    Also called SX-682

    Given PO

  • Daratumumab and Recombinant Human HyaluronidaseDrug

    Also called Daratumumab and hyaluronidase

    Given SC

  • CarfilzomibDrug

    Also called CFZ, PR 171

    Given IV

  • DexamethasoneDrug

    Also called Adexone, Baycadron, Cortidexason, Decadrol

    Given PO

  • Biospecimen CollectionProcedure or surgery

    Undergo Blood sample collection

  • Bone Marrow AspirationProcedure or surgery

    Undergo Bone Marrow Aspiration

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo ECHO

  • Positron Emission TomographyProcedure or surgery

    Also called PET, PET Scan

    Undergo PET/CT

  • Computed TomographyProcedure or surgery

    Also called CAT Scan

    Undergo PET/CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called MRI Scan

    Undergo MRI

Study groups in NCT06622005
Study groupRoleWhat they receive
TreatmentExperimentalPatients receive SX-682 PO BID on days 1-21 of each cycle. Patients also receive daratumumab-hyaluronidase SC once weekly on cycles 1 and 2 and once every 2 weeks on cycles 3-6 and carfilzomib IV on days 1, 8 and 15 and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with sustained response after 6 cycles may continue to receive SX-682 PO BID on days 1-21, daratumumab-hyaluronidase SC on day 1, carfilzomib IV on days 1, 8, and 15 and dexamethasone PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, BM aspiration, ECHO and PET/CT or MRI on study.
Receives: Drug: Cxcr1/2 Inhibitor SX-682; Drug: Daratumumab and Recombinant Human Hyaluronidase; Drug: Carfilzomib; Drug: Dexamethasone; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Echocardiography; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: WIthin the first 28 days of start of treatment

Secondary outcomes (4)

  1. Percentage of Overall response rate

    Obtained using Jeffrey's prior method

    Measured: Up to 3 years after last patient is enrollled

  2. Percentage of Progression-free survival

    Determined using Kaplan-Meier estimates

    Measured: Up to 3 years after last patient is enrolled

  3. Percentage of Overall Survival

    Determined using Kaplan-Meier estimates

    Measured: 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.

    Measured: Within the first 6 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start10 Apr 2025
  3. Primary completion10 Apr 2027 (estimated)
  4. Study completion10 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06622005
Sponsor's protocol ID
I-3850824
Status last verified
Aug 2026
First submitted
30 Sep 2024
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cxcr1/2 Inhibitor SX-682, Daratumumab and Recombinant Human Hyaluronidase and Carfilzomib in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ASK RPCI (1-877-275-7724, askrpcil@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicity (time frame: WIthin the first 28 days of start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06622005.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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