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Recurrent Multiple MyelomaPhase 1NCT07082270

Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma

A Phase 1 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by Roswell Park Cancer Institute at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I trial studies the side effects and best dose of selvigaltin when given together with standard of care treatment (daratumumab-hyaluronidase, carfilzomib, dexamethasone) in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Apr 2026to 1 Feb 2028
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Age ≥ 18 years
  • RRMM with measurable disease prior to initiation of study intervention. Measurable disease must include at least one of the following criteria:
  • Serum M-protein > 0.5 g/dL or,
  • Urine M-protein > 200 mg/24h or,
  • Serum free light chain assay: involved free light chain (FLC) level > 100 mg/L provided serum free light chain ratio is abnormal or,
  • Bone marrow plasma cells > 10% of total bone marrow cells
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  • Have received ≥ 1 prior line of therapy
  • Planned treatment with the standard of care regimen of daratumumab, carfilzomib, and dexamethasone (Dara-KD) regimen
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Absolute neutrophil count: ≥ 1,000 /µL
  • Platelets: ≥ 75,000 /µL
  • 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
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
  • Left ventricular ejection fraction of at least 50% by ECHO or MUGA
  • 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
  • Participants 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

  • Known hypersensitivity to selvigaltin or any of the excipients
  • Prior hypersensitivity or grade 3 skin toxicity with daratumumab/carfilzomib
  • Exposure to prior daratumumab/carfilzomib is permitted, however refractoriness within 6 months of study initiation is exclusionary
  • Concomitant medication(s) known to be (a) a strong inhibitor or inducer of CYP3A4, (b) strong P-gp/MDRI inhibitors or inducers or, (c) QT interval (QT) prolonging as defined in the drug's 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 interval (QTc) interval > 470 msec without a bundle block or patients with congenital long QT syndrome
  • Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina or congestive heart failure in the last 6 months
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  • 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
  • Known active bacillus tuberculosis infection
  • Known active HIV unless CD4+ > 350 cells/µL, no history of AIDS-defining opportunistic infection within the past 12 months, or on effect anti-retroviral therapy (ART) with > 4 weeks on treatment and viral load < 400 copies/mL. Confirm low risk of drug-drug interactions or are able to be substituted
  • Pregnant or nursing female participants
  • 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.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: Phase I Trial of GB1211 (Selvigaltin), an Oral Galectin-3 (Gal-3) Inhibitor, Combined With Standard of Care Treatment in Relapsed/Refractory Multiple Myeloma (RRMM)

This phase I trial studies the side effects and best dose of selvigaltin when given together with standard of care treatment (daratumumab-hyaluronidase, carfilzomib, dexamethasone) in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Selvigaltin works by blocking the activity of a protein called galectin-3. Galectin-3 is involved in various cellular processes, including inflammation and tissue scarring, which is associated with worse outcomes in several forms of cancer. By blocking the activity of galectin-3, selvigaltin may help reduce inflammation and tissue scarring. Daratumumab-hyaluronidase is a drug composed of daratumumab and hyaluronidase. 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 cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Hyaluronidase helps deliver the daratumumab to CD38-expressing cancer cells. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving selvigaltin with standard of care treatment may be safe, tolerable, and/or effective in treating patients with relapsed or refractory multiple myeloma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety and tolerability of selvigaltin in combination with standard of care treatment regimen (daratumumab, carfilzomib, and dexamethasone) for relapsed/refractory multiple myeloma (RRMM).

II. Determine the maximal tolerated dose (MTD) of selvigaltin in combination with a standard of care treatment regimen (daratumumab, carfilzomib, and dexamethasone) for RRMM.

SECONDARY OBJECTIVES:

  1. To collect safety and preliminary efficacy data. II. Rate of bone marrow measurable residual disease (MRD) negativity.

EXPLORATORY OBJECTIVE:

  1. To assess the effects of the combination treatment on the tumor microenvironment (TME) and on immune cell subsets in the peripheral blood and bone marrow.

OUTLINE: This is a dose-escalation study of selvigaltin in combination with daratumumab and recombinant human hyaluronidase (daratumumab-hyaluronidase), carfilzomib, and dexamethasone followed by a dose-expansion study.

Patients receive selvigaltin orally (PO) twice daily (BID) on days 1-28 of each cycle, daratumumab-hyaluronidase subcutaneously (SC) on days 1, 8, 15, and 22 of cycles 1-2 and days 1 and 15 of cycles 3-6, carfilzomib intravenously (IV) over 30 minutes on days 1, 8, and 15 of each cycle, 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 who respond to treatment may optionally continue to receive treatment beyond 6 cycles with selvigaltin PO BID on days 1-28 of each cycle, daratumumab-hyaluronidase SC on day 1 of each cycle, carfilzomib IV over 30 minutes on days 1, 8, and 15 of each cycle, 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 echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening and blood sample collection and bone marrow aspiration and biopsy throughout the trial. Patients also undergo positron emission tomography (PET)/computed tomography (CT), magnetic resonance imaging (MRI), and/or CT during screening and optionally during 1 year follow up.

After completion of study treatment, patients that remain on treatment beyond 6 cycles are followed up monthly until disease progression and then every 3 months for up to 3 years. Patients that do not continue treatment are followed up at 30 days and then every 3 months for up to 3 years or until start of a new treatment, disease progression, or death, whichever occurs first.

Being tested
Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Carfilzomib, Computed Tomography
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspiration

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • CarfilzomibDrug

    Also called Carfilnat, CFZ, Kyprolis, PR 171

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT and/or CT

  • Daratumumab and Recombinant Human HyaluronidaseDrug

    Also called DARA Co-formulated with rHuPH20, DARA/rHuPH20, Daratumumab + rHuPH20, Daratumumab and Hyaluronidase

    Given SC

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo ECHO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

  • SelvigaltinDrug

    Given PO

Study groups in NCT07082270
Study groupRoleWhat they receive
Treatment (selvigaltin, Dara-KD)ExperimentalSee Detailed Description.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Drug: Carfilzomib; Procedure: Computed Tomography; Drug: Daratumumab and Recombinant Human Hyaluronidase; Drug: Dexamethasone; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Selvigaltin

What is being measured

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

  1. Incidence of dose limiting toxicities (DLTs)

    As assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v) 5.0. The DLTs will be summarized by dose level using frequencies and relative frequencies.

    Measured: Up to 28 days

  2. Maximum tolerated dose (MTD)

    Will determine the MTD of selvigaltin when administered in combination with daratumumab, carfilzomib, and dexamethasone (DaraKD). Will employ the Bayesian optimal interval design to find the MTD.

    Measured: Up to 28 days

  3. Recommended phase 2 dose (RP2D)

    Will determine the RP2D of selvigaltin when administered in combination with DaraKD. The RP2D will be determined by evaluating both the toxicity profile and the therapeutic response.

    Measured: Up to 28 days

Secondary outcomes (8)

  1. Incidence of overall adverse events

    As assessed by the NCI CTCAE v5.0.

    Measured: Up to 6 cycles (Cycle length = 28 days)

  2. Incidence of serious adverse events

    As assessed by the NCI CTCAE v5.0.

    Measured: Up to 6 cycles (Cycle length = 28 days)

  3. Overall response rate

    As per investigator's assessment using the International Myeloma Working Group criteria will be summarized as proportions and 90% Clopper-Pearson confidence intervals by dose levels.

    Measured: During or after 6 cycles of therapy, assessed up to 3 years (Cycle length = 28 days)

  4. Duration of response

    Measured: During or after 6 cycles of therapy, assessed up to 3 years (Cycle length = 28 days)

  5. Progression free survival

    Will be summarized using Kaplan-Meier estimators by dose levels.

    Measured: From the start of treatment until the first occurrence of disease progression or death from any cause, whichever comes first, assessed up to 3 years

  6. Overall survival

    Will be summarized using Kaplan-Meier estimators by dose levels.

    Measured: From the start of treatment to death from any cause, assessed up to 3 years

  7. Patient reported outcomes

    As assessed using the European Organization for the Research and Treatment of Cancer Quality of Life-Core 30 questionnaire. Will be summarized by dose levels and time points. Generalized linear mixed models will be used for within-subject comparisons between time points.

    Measured: At baseline, cycle 4 day 1, and 30 days after last dose of study drug

  8. Bone marrow measurable residual disease (MRD) status

    The MRD status will be summarized as frequencies and relative frequencies by dose levels.

    Measured: After 6 cycles (Cycle length = 28 days)

Timeline

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

  1. First posted24 Jul 2025
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Why it stopped: Sponsor withdrawal of supplying investigational drug

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07082270
Sponsor's protocol ID
I-4514825
Other IDs
NCI-2025-04757, I-4514825
Status last verified
May 2026
First submitted
16 Jul 2025
Last updated
15 May 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 Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy 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 11 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: withdrawn, as of the sponsor's last update on 15 May 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (DLTs) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. 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 NCT07082270.

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 15 May 2026.

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