This trial is evaluating whether Denosumab will improve 1 primary outcome and 4 secondary outcomes in patients with Smoldering Multiple Myeloma. Measurement will happen over the course of 1 year.
This trial requires 20 total participants across 2 different treatment groups
This trial involves 2 different treatments. Denosumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
Recent findings indicate that, during the development of smoldering myeloma, an over-activation or dysregulation of the immune system as well as an excess of free light chains may be involved.
Patients with smoldering [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) present with nonspecific systemic symptoms such as unremitting fatigue or a decrease in quality of life, which has a significant impact on the quality of life. The occurrence of bone pain, anemia, and monoclonal proteinuria in smoldering patients is similar to that previously reported for patients with myeloma.
SMM is difficult to cure. Relapse may not cause overt organ damage; alternatively, complications and death may result from treatments of SMM. At this early stage, new therapies should be tried to prevent overt clinical disease.
Patients with the disease show a good response to standard chemotherapy regimens; however, it is often inadequate. Findings from a recent study, a low percentage of responders was noted, and most required additional chemotherapy as part of the treatment. Most patients had a short and rapid response to standard regimens. Further investigations may define a role for more targeted therapies or immunocompression therapy.
Symptoms of SMM are similar to those of AL amyloidosis; however, symptoms are slightly earlier. Although the physical examination, hematological, serum biochemical, and urine dipstick analyses are normally carried out, radiological studies may be requested if a clinical suspicion of SMM arises. The diagnosis of SMM requires a high level of clinical suspicion, corroborated by a thorough clinical history and physical examination.
As of August 2007, a total of 1,928 SMM cases were reported to the SEER database, of which 439 (24%, or 1.08 million) were reported to be SM M+s. SM M+s are more common among whites but also occur in blacks and Hispanics, two racially mixed patient populations. The mean age at diagnosis has increased over time; the most recent mean age at diagnosis was 48 years for whites and 57 years for blacks.
In the short term, denosumab administered by intramuscular or subcutaneous routes was well tolerated. No unexpected adverse effects were reported in this first-in-human study with denosumab administered by these routes.
Based on data from the phase 3 REACH trial, denosumab therapy in relapsed/refractory SMM improved CRF-RS, FRAX, and EQ-5D. These improvements persisted at the 12-month follow-up and after adjustment for treatment.
Patients with MM, even in the indolent MM and in remission, are at high risk for secondary malignancies and require a close follow-up for early detection and prevention of the progression to overt myeloma.
Denosumab, an intravenous bone remodeling agent, was shown to be more effective and safer than the conventional therapies for newly diagnosed myeloma patients with disease refractory to the frontline therapy. No new adverse drug reactions were reported. Denosumab appears to be more efficient than bortezomib for treatment of multiple myeloma, and it appears to have a much better response rate than lenalidomide for patients with newly diagnosed myeloma; therefore, it is preferable to denosumab for initial line treatment in patients with myeloma.
The first report of denosumab treatment in patients with SMM includes a patient with a baseline creatinine of 5.6 mg/dL. Denosumab treatment reduced creatinine to 1.5 mg/dL at week 20 in 4 patients with SMM, although it continued to be prescribed to another patient with SMM with a creatinine at week 21 below the inclusion criterion. An additional 7 patients with SMM were switched from adalimumab to denosumab after week 21 of treatment (mean creatinine at week 21-4.8; range: 1.5-17.
Treatment of patients with the biosimilar, denosumab, is similar to that for the original agent, bisphosphonate. Denosumab can be taken once weekly, and many physicians prefer to take denitbsl once a week to avoid injection pain and potential injection site reactions. When denosumab treatment is needed for a longer period of time, denonosumab can be taken every two weeks, as it does not show an increased risk of developing osteonecrosis of the jaw when taken more frequently than once weekly.