Rochester, NYNCT05597345Now EnrollingIRB Ready

Smoldering Multiple Myeloma Clinical Trial in Rochester, NY

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

Sponsored by University of Rochester

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Expert Care in Rochester

Access smoldering multiple myeloma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related smoldering multiple myeloma treatment provided free

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Check if you qualify for this smoldering multiple myeloma clinical trial in Rochester, NY

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Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for NY 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 Rochester site if eligible
  4. 4Begin participation

About This Smoldering Multiple Myeloma Study in Rochester

Selinexor is a drug that has been approved in the treatment of patients with symptomatic multiple myeloma. The standard of care for patients with Smoldering Multiple Myeloma remains observation, but there are numerous clinical trials investigating interventions to delay progression to multiple myeloma and prevent or delay disease related outcomes. A subset of patients with intermediate or high risk smoldering multiple myeloma have a much higher risk of progressive to multiple myeloma, while the low risk smoldering myeloma patient population has a much lower risk. This is a clinical trial investigating the use of low-dose selinexor in patients with intermediate to high-risk smoldering multiple myeloma. The investigators hypothesize that the use of selinexor in intermediate to high risk smoldering myeloma patients will help to delay progression of disease to symptomatic multiple myeloma.

Sponsor: University of Rochester

Who Can Participate

Inclusion Criteria

Age \>/= 18 years
Histologically confirmed diagnosis of SMM according to the IMWG definition: serum M-protein \>/= 3 g/dL or BMPC \>10% but \<60%, or both.
Should not meet CRAB criteria: hypercalcemia, anemia, bone lesions, or renal insufficiency thought to be related to the plasma cell disorder.
Should have 1 of the following risk factors to be considered intermediate risk and 2 or more risk factors to be considered high-risk:
BMPC\>/=20%
M-spike \>/= 2g/dL
Involved to uninvolved sFLC ratio of \>/= 20
normal hepatic function within 28 days prior to C1D1
Adequate renal function within 28 days prior to C1D1. Estimated creatinine clearance (CrCl) calculated using formula of Cockcroft and Gault. CrCl \>/= 15 mL/min.
Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count (ANC)\>/=1.5 x10\^9/L, hemoglobin \>/=10g/dL, platelets \>/150x10\^9/L.
Life expectancy of \>12 months.
ECOG PS 0-1
Subjects with reproductive potential must use 2 highly effective methods of effective contraception or practice sexual abstinence throughout the study and continue for 6 months after the study has closed. Subjects who are surgically sterile (e.g., history of bilateral tubal ligation, hysterectomy, or whos partner is sterile are not required to use additional modes of contraception.
Ability to understand and willingness

Exclusion Criteria

Meets criteria for symptomatic MM as defined by any of the following, determined to be related to the plasma cell disorder
Hypercalcemia (corrected serum calcium \>11.0 mg/dL)
Renal insufficiency (creatinine \>2.0 mg/dL)
Anemia (hemoglobin \<10g/dL)
One or more osteolytic bone lesions on radiography, but more than one lesion required if \<10% clonal bone marrow plasma cells. Based on MRI imaging, there must be more than one lesion \>5mm in size.
Clonal bone marrow plasma cells ≥60%
An involved serum free light chain ≥ 100mg/L with the ratio of the involved/uninvolved free light chains also ≥100
Documented systemic light chain amyloidosis
Systemic corticosteroids \>10mg prednisone (or equivalent) daily for other medical conditions.
Active invasive malignancy within the past 3 years that may affect the results or interfere with the interpretation of results of this study.
Non-invasive malignancy that was not treated with curative intent within the past 3 years that may affect the results or interfere with the interpretation of the results of this study.
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 14 days of the receiving the first dose
Known active HIV infection without adequate anti-retroviral therapy
Active gastrointestinal dysfunction that prevents patient from swallowing tablets or may interfere with absorption of study treatment
Pregnant, breast feeding, or planning to become pregnant within 6 months after the end of treatment.
Subject of reproductive potential that is not willing to use two methods of highly effective contraception during treatment period and for 6 months after the end of treatment.
Any major medical or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
Prior exposure to a SINE compound, including Selinexor.

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 Rochester?

Yes, this clinical trial (NCT05597345) has an active research site in Rochester, NY 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.

Smoldering Multiple Myeloma Treatment Options in Rochester, NY

If you're searching for smoldering multiple myeloma treatment options in Rochester, NY, this clinical trial (NCT05597345) 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 Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced smoldering 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 smoldering multiple myeloma clinical trials near you to find additional studies recruiting in your area.

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