Jacksonville, FLNCT05847569Now EnrollingIRB Ready

Recurrent Multiple Myeloma Clinical Trial in Jacksonville, FL

Access cutting-edge recurrent multiple myeloma treatment through this clinical trial at a research site in Jacksonville. Study-provided care at no cost to qualified participants.

Sponsored by Mayo Clinic

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Expert Care in Jacksonville

Access recurrent multiple myeloma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related recurrent multiple myeloma treatment provided free

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Check if you qualify for this recurrent multiple myeloma clinical trial in Jacksonville, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Jacksonville

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Jacksonville site if eligible
  4. 4Begin participation

About This Recurrent Multiple Myeloma Study in Jacksonville

This phase II trial tests alternate doses and dosing schedules of belantamab mafodotin in treating patients with triple-class multiple myeloma that has come back (after a period of improvement) (recurrent) and/or does not respond to treatment (or that has not responded to previous treatment) (refractory). Belantamab mafodotin is a monoclonal antibody, belantamab, linked to a chemotherapy drug, mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. This trial may help researchers determine if alternate doses and dosing schedules work better in preventing certain side effects, such as eye toxicity, and treating patients with recurrent or refractory multiple myeloma.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

Age \>= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
Histologically or cytologically confirmed diagnosis of multiple myeloma (MM), as defined in International Myeloma Working Group (IMWG) criteria, and:
If patients have undergone stem cell transplantation (SCT), day 0 of SCT must be \> 100 days prior to registration to be eligible for the study
Has had disease progression after \>= 3 prior lines of anti-myeloma treatments including one proteasome inhibitor (eg. bortezomib, carfilzomib or ixazomib), one immunomodulatory agent (eg.thalidomide, lenalidomide or pomalidomide) and one anti-CD38 monoclonal antibody (eg.daratumumab or isatuximab)
Prior non-belantamab mafodotin anti-BCMA agent exposure is allowed; patients with prior treatment with an anti-BCMA chimeric antigen receptor (CAR)-T or bispecific antibody will be allowed to participate in the study
Has measurable disease with at least one of the following:
Serum M-protein \>= 0.5 g/dL (\>= 5 g/L)
Urine M-protein \>= 200 mg/24 h
Serum free light chain (FLC) assay: Involved FLC level \>= 10 mg/dL (\>= 100 mg/L) and an abnormal serum free light chain ratio (\< 0.26 or \> 1.65)
Note: Patients with non-secretory disease will be allowed to participate
Absolute neutrophil count \>= 0.75 x 10\^9/L (=\< 28 days prior to registration)
Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin
Hemoglobin \>= 7.0 g/dL (=\< 28 days prior to registration)
Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin
Platelets \>= 50 x 10\^9/L (=\< 28 days prior to registration)
Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin
Total bilirubin =\< 2.0 x upper limit of normal (ULN) (=\< 28 days prior to registration); (total bilirubin \>= 2.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \< 35%)
Alanine aminotransferase =\< 2.5 x ULN (=\< 28 days prior to registration)
Aspartate transaminase =\< 2.5 x ULN (=\< 28 days prior to registration)
Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/1.73 m\^2 (=\< 28 days prior to registration)
As calculated by Modification of Diet in Renal Disease (MDRD) formula
Spot urine \[albumin/creatinine ratios (spot urine)\] =\< 500 mg/g (56 mg/mmol) OR urine dipstick negative/trace \[if \>1+ only eligible if confirmed =\< 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void)\] (=\< 28 days prior to registration)
Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only. Both females and males must agree to follow the instructions
NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Provide written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol
Willingness to provide mandatory blood specimens for correlative research
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Exclusion Criteria

Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, myeloma protein, and skin changes), Waldenstrom Macroglobulinemia
Prior belantamab mafodotin therapy. However, patients with prior exposure to another non-belantamab mafodotin anti-BCMA agent such as an anti-BCMA CAR-T or anti-BCMA bispecific antibody will be allowed to participate in the study
Systemic active infection requiring treatment
Any unresolved toxicity \>= grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to grade 2
Any major surgery =\< 4 weeks prior to registration
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities except renal impairment) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures
Evidence of active mucosal or internal bleeding
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria
Participants with previous or concurrent malignancies other than multiple myeloma are excluded, unless the prior malignancy has been considered medically stable for \> 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. NOTE: Participants with curatively treated nonmelanoma skin cancer are allowed without a 2-year restriction.
Evidence of cardiovascular risk, including any of the following:
Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz type II) or 3rd degree atrioventricular (AV) block
History of myocardial infarction (=\< 6 months), acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 12 weeks of screening
Class III or IV heart failure as defined by the New York Heart Association functional classification system \[NYHA, 1994\]
Uncontrolled hypertension
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment
Known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:
Established anti-retroviral therapy (ART) for at \>=4 weeks and HIV viral load \< 400 copies/mL
CD4+ T-cell (CD4+) counts \>= 350 cells/uL
No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections \< 12 months prior
Note: consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant
Patients with hepatitis B will be excluded unless the following criteria can be met:
If patient's serology shows hepatitis B virus core antibody (HbcAb)+ and hepatitis B surface antigen (HbsAg)-, they must have undetectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at screening. Patients will be monitored per protocol. Antiviral treatment would be instituted if HBV DNA becomes detectable
If patient's serology shows HBsAg+ at screen or within 3 months prior, patients must have undetectable HBV DNA at screening, must have started highly effective antiviral treatment at least 4 weeks prior to registration, and must have baseline imaging per protocol (patients with cirrhosis are excluded). Patients must remain on antiviral treatment throughout the study. Patients will be monitored per protocol
Note: presence of hepatitis (Hep) B surface antibody (HBsAb) indicating previous vaccination will not exclude a participant.
Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or =\< 12 weeks prior to first dose of study treatment unless the participant can meet the following criteria:
RNA test negative
Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period \>= 4 weeks
Current corneal epithelial disease except for mild punctuate keratopathy
Participant who received plasmapheresis within =\< 7 days prior to registration
Patients who received prior allogeneic stem cell transplant
Participant who received a live or live-attenuated vaccine =\< 30 days prior to registration. Ok to receive coronavirus disease (COVID) vaccine at any timepoint during protocol treatment
Participant is a woman who is pregnant or lactating
Participant who plans on wearing contact lenses during treatment with belantamab mafodotin Lifestyle Considerations: Contact lenses are prohibited for participants while they are receiving belantamab mafodotin treatment. Contact lens use may be restarted after belantamab mafodotin treatment is discontinued, provided a qualified eye care specialist confirm there are no other contraindications. Use of bandage contact lenses is allowed for the treatment of corneal epithelial disease as prescribed by an ophthalmologist/eye care professional. No other lifestyle restrictions are required for participants in this study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Jacksonville?

Yes, this clinical trial (NCT05847569) has an active research site in Jacksonville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent Multiple Myeloma Treatment Options in Jacksonville, FL

If you're searching for recurrent multiple myeloma treatment options in Jacksonville, FL, this clinical trial (NCT05847569) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Jacksonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent multiple myeloma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent multiple myeloma clinical trials near you to find additional studies recruiting in your area.

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