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New treatment option for Smoldering Plasma Cell Myeloma
Official title Iberdomide Alone or in Combination With Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma
ClinicalTrials.gov ID: NCT04776395
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for smoldering plasma cell myeloma.
Also referred to as Aacidexam, Adexone.
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
- This phase II trial studies the effects of iberdomide when given alone or in combination with dexamethasone in treating intermediate or high-risk smoldering multiple myeloma patients. Immunotherapy with iberdomide may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Subject must have intermediate- or high risk smoldering multiple myeloma (SMM) as confirmed by at least one of the following factors either at...
- Bone marrow clonal plasma cells \>= 20% confirmed on either screening bone marrow biopsy or by outside pathology ≤5 years from initiation of study...
- Abnormal serum free light chain ratio \> 20 by serum free light chain (FLC) assay
- Serum monoclonal protein \>= 2 g/dL
- Subject must have been diagnosed with SMM =\< 5 years from initiation of study drug
You likely can't join if
- Multiple myeloma requiring treatment as defined by SLiM-CRAB criteria
- Monoclonal gammopathy of undetermined significance (MGUS), polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes...
- Concurrent intravenous bisphosphonate use more often than once a year
- Prior or ongoing treatment for plasma cell disorder
- Active hepatitis B or C due to risk of infection made worse by study drug
- If subject has human immunodeficiency virus (HIV), they must have a CD4 count \>= 350, no history of acquired immune deficiency syndrome-related...
See the full eligibility criteria
- Subject must have intermediate- or high risk smoldering multiple myeloma (SMM) as confirmed by at least one of the following factors either at screening or within 28 days of screening:
- Bone marrow clonal plasma cells \>= 20% confirmed on either screening bone marrow biopsy or by outside pathology ≤5 years from initiation of study drug.
- Abnormal serum free light chain ratio \> 20 by serum free light chain (FLC) assay
- Serum monoclonal protein \>= 2 g/dL
- Subject must have been diagnosed with SMM =\< 5 years from initiation of study drug
- Both men and women of all races and ethnic groups are eligible for this study
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky \>= 60%) is required for eligibility
- Absolute neutrophil count (ANC) \>= 1500/uL
- Hemoglobin (Hgb) \> 11 g/dL
- Platelet count \>= 100,000 cells/mm\^3 and must be platelet and packed red blood cells (PRBC) transfusion independent with no granulocyte colony-stimulating factor (G-CSF) to ensure eligibility within 8 weeks of...
- Estimated creatinine clearance \>= 30 mL/min as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or Cockcroft-Gault
- Total bilirubin \< 2 mg/dL except in people with congenital bilirubinemia such as Gilbert syndrome, in which case direct bilirubin =\< 2 times the institutional upper limit of normal is required
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times the institutional upper limit of normal
- Left ventricular ejection fraction \>= 40%
- Females of childbearing potential (FCBP) must have two negative pregnancy tests as verified by the investigator prior to starting study treatment. The effects of Iberdomide on the developing human fetus are unknown. For...
- Female of childbearing potential (FCBP) is a sexually mature woman who:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- The subject must be willing to comply with fertility requirements as below:
- Male people must agree to use an adequate method of contraception for the duration of the study and for 3 months afterwards
- Female people must be either postmenopausal, free from menses \>= 2 years (yrs), surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from...
- Patients must agree not to donate blood, sperm/ova while taking protocol therapy and for at least 4 weeks after stopping treatment
- Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements
- people with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Multiple myeloma requiring treatment as defined by SLiM-CRAB criteria
- Monoclonal gammopathy of undetermined significance (MGUS), polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS syndrome), plasma cell leukemia, primary systemic light chain (AL)...
- Concurrent intravenous bisphosphonate use more often than once a year
- Prior or ongoing treatment for plasma cell disorder
- Active hepatitis B or C due to risk of infection made worse by study drug
- If subject has human immunodeficiency virus (HIV), they must have a CD4 count \>= 350, no history of acquired immune deficiency syndrome-related illness, and not currently prescribed zidovudine or stavudine
- people may be receiving concomitant low dose corticosteroids (e.g., prednisone up to but no more than 10 mg by mouth daily or its equivalent) for symptom management and comorbid conditions
- Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, cardiac arrhythmia...
- people with gastrointestinal disease that may significantly alter the absorption of iberdomide
- Pregnant women are excluded from this study because protocol therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants...
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of iberdomide. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (e.g...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, 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 Atlanta, Georgia, 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.