Active — Not RecruitingPhase 2

Isatuximab With or Without Lenalidomide in Patients With High Risk Smoldering Multiple Myeloma (ISAMAR)

United States61 participantsStarted 2017-02-08

Plain-language summary

This is a multi-center, open label, phase II study designed to evaluate the efficacy of isatuximab with or without lenalidomide when given to patients with high risk smoldering multiple myeloma.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓Risk factors for progression to multiple myeloma in patients with smoldering multiple myeloma (SMM) have been identified and include: percentage of bone marrow involvement by plasma cells, monoclonal spike in blood, serum free light chains in blood, presence or absence of immunoparesis in blood, percentage of normal versus abnormal plasma cells in the bone marrow compartment by using standard flow cytometry techniques and gene expression profiling of plasma cells obtained from a bone marrow aspirate.
✓. Serum monoclonal protein (IgG or IgA) ≥ 3 g/dL or urinary monoclonal protein ≥ 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60%
✓. Absence of myeloma defining events or amyloidosis

Exclusion criteria

✕. Hypercalcemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \> 2.75 mmol/L (\> 11 mg/dL)
✕. Renal Insufficiency: creatinine clearance \< 50 ml/min or serum creatinine \> 2 mg/dL
✕. Anemia: hemoglobin value \<10 g/dL or 2 g/dL \< normal reference
✕. Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2\[F-18\] fluoro-D-glucose positron emission tomography CT (PET-CT).
✕. Clonal bone marrow plasma cell percentage ≥ 60%
✕. Involved: uninvolved serum free light chain ratio ≥100 measured by Freelite assay (The Binding Site Group, Birmingham, UK)
✕. \>1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size)

What they're measuring

Overall response (>= partial response)

Timeframe: 6 months

Trial details

NCT IDNCT02960555

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

View on ClinicalTrials.gov More Smoldering Plasma Cell Myeloma trials