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

NCT07082270 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: I-4514825NCI-2025-04757
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Recurrent Multiple Myeloma; Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 28 days

• 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.

  Up to 28 days

• 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.

  Up to 28 days

Secondary Outcomes (8)

• Incidence of overall adverse events

  Up to 6 cycles (Cycle length = 28 days)

• Incidence of serious adverse events

  Up to 6 cycles (Cycle length = 28 days)

• Overall response rate

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

• Duration of response

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

• Progression free survival

  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

Study Arms (1)

Treatment (selvigaltin, Dara-KD)

EXPERIMENTAL

See Detailed Description.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (selvigaltin, Dara-KD)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow aspiration

Treatment (selvigaltin, Dara-KD)

Carfilzomib DRUG

Given IV

Also known as: Carfilnat, CFZ, Kyprolis, PR 171, PR-171, PR171

Treatment (selvigaltin, Dara-KD)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Treatment (selvigaltin, Dara-KD)

Computed Tomography PROCEDURE

Undergo PET/CT and/or CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (selvigaltin, Dara-KD)

Daratumumab and Recombinant Human Hyaluronidase DRUG

Given SC

Also known as: DARA Co-formulated with rHuPH20, DARA/rHuPH20, Daratumumab + rHuPH20, Daratumumab and Hyaluronidase, Daratumumab and Hyaluronidase-fihj, Daratumumab and vorhyaluronidase, Daratumumab and Vorhyaluronidase Alfa, Daratumumab with rHuPH20, Daratumumab-rHuPH20, Daratumumab/Hyaluronidase-fihj, Daratumumab/rHuPH20 Co-formulation, Darzalex Faspro, Darzalex/rHuPH20, Darzquro, HuMax-CD38-rHuPH20, Recombinant Human Hyaluronidase Mixed with Daratumumab

Treatment (selvigaltin, Dara-KD)

Dexamethasone DRUG

Given PO

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, LenaDex, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Treatment (selvigaltin, Dara-KD)

Echocardiography Test PROCEDURE

Undergo ECHO

Also known as: EC, Echocardiography

Treatment (selvigaltin, Dara-KD)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (selvigaltin, Dara-KD)

Multigated Acquisition Scan PROCEDURE

Undergo MUGA

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

Treatment (selvigaltin, Dara-KD)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Treatment (selvigaltin, Dara-KD)

Questionnaire Administration OTHER

Ancillary studies

Treatment (selvigaltin, Dara-KD)

Selvigaltin DRUG

Given PO

Treatment (selvigaltin, Dara-KD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Known hypersensitivity to selvigaltin or any of the excipients
• Prior hypersensitivity or grade 3 skin toxicity with daratumumab/carfilzomib
• 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
• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Specimen Handling; Biopsy; carfilzomib; daratumumab; Hyaluronoglucosaminidase; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Hamza Hassan

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)