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New treatment option for Smoldering Multiple Myeloma
Official title Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma
ClinicalTrials.gov ID: NCT05597345
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, being studied as a potential treatment for smoldering multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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%
You likely can't join if
- 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 \ 5mm in size.
- Clonal bone marrow plasma cells ≥60%
See the full eligibility 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
- people 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. people who are...
- Ability to understand and willingness
- 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.