CompletedPhase 2

Denosumab for Smoldering Multiple Myeloma

United States20 participantsStarted 2019-04-19

Plain-language summary

This study will assess the safety and tolerability of denosumab in smoldering multiple myeloma subjects as well to see if denosumab can reduce subjects' risk of getting multiple myeloma.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient has confirmed SMM according to the definition of the International Myeloma Working Group (IMWG) definition: serum M-protein ≥3 g/dL or BMPC \>10% but less than 60%, or both, along with normal organ and marrow function (CRAB) within 4 weeks prior to baseline. C: Absence of hypercalcemia, evidenced by a calcium ≤11 mg/dL. R: Absence of renal failure, evidenced by a creatinine ≤ 2.0mg/dL A: Absence of anemia, evidenced by a hemoglobin ≥10 g/dL.
✓. One of the risk factors below that portends for an increased risk of progression to MM:
✓. Serum calcium or albumin-adjusted serum calcium ≥ 2.1 mmol/L (8.4 mg/dL) and ≤ 2.9mmol/L (11.5 mg/dL) (Reference range 8.5-10.8 mg/dL)
✓. Able to tolerate daily supplementation of calcium and vitamin D
✓. Must have a vitamin D level ≥ 30 ng/mL after repletion
✓. Participants must have normal organ as defined below:
✓. Age ≥ 18 years.
✓. ECOG PS ≤1

Exclusion criteria

✕. Prior administration of denosumab.
✕. Any history of IV bisphosphonate use prior to or during the study
✕. Prescription oral fluorides or bisphosphonate usage \> 3 months within the past 2 years
✕. Systemic corticosteroids \> 10mg prednisone per day
✕. Known secondary cause for osteopenia or osteoporosis
✕. Patient has symptomatic MM, as defined by any of the following:
✕. Other: symptomatic hyperviscosity, amyloidosis, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein)
✕. Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw.

What they're measuring

Proportion of Subjects With a Downgraded Risk of Progression of Smoldering Multiple Myeloma if the Risk Category Decreases.

Timeframe: 1 year

Trial details

NCT IDNCT03839459

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-16

Results submitted2023-01-19

View on ClinicalTrials.gov More Smoldering Multiple Myeloma trials