Denosumab for Smoldering Multiple Myeloma

1
Effectiveness
2
Safety
University of Rochester, Rochester, NY
Smoldering Multiple Myeloma+2 More
Denosumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Smoldering Multiple Myeloma

Study Summary

This study is evaluating whether a drug may help reduce the risk of multiple myeloma.

See full description

Eligible Conditions

  • Smoldering Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

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.

1 year
Proportion of subjects with Skeletal related Events
Proportion of subjects with a downgraded risk of progression of smoldering multiple myeloma if the risk category decreases.
Proportion of subjects with change in bone mineral density
Proportion of subjects with disease progression to Multiple Myeloma
3 year
Proportion of subjects with progression free survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Side Effects for

Denosumab
Contusion
11%
Post procedural discomfort
11%
Constipation
11%
Rash
6%
Nasopharyngitis
6%
Diarrhoea
3%
Appendicitis
3%
Bronchitis
3%
Pruritus
3%
Deep vein thrombosis
3%
Fatigue
3%
Pain in extremity
3%
Groin pain
3%
Skin induration
3%
Hypokalaemia
3%
Arthralgia
3%
Tremor
3%
Cough
3%
Fall
0%
Abdominal discomfort
0%
Nausea
0%
Dizziness
0%
Hypotension
0%
Bone pain
0%
Urine abnormality
0%
Chest pain
0%
Joint stiffness
0%
Tendon disorder
0%
Dysgeusia
0%
Oropharyngeal pain
0%
Headache
0%
Dry eye
0%
Gastroenteritis
0%
Joint swelling
0%
Vaginal discharge
0%
Abdominal pain lower
0%
Bladder spasm
0%
Thirst
0%
Local swelling
0%
Onychoclasis
0%
Sensation of heaviness
0%
Sneezing
0%
Loss of consciousness
0%
Abdominal pain
0%
Ear infection
0%
Lung adenocarcinoma
0%
Lymph node pain
0%
Muscular weakness
0%
Basal cell carcinoma
0%
Gastrooesophageal reflux disease
0%
Injection site erythema
0%
Foot deformity
0%
Nephrolithiasis
0%
Urticaria
0%
Swelling face
0%
Haematoma
0%
Hyperhidrosis
0%
Chronic obstructive pulmonary disease
0%
Alopecia
0%
Spider vein
0%
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01753856) in the Denosumab ARM group. Side effects include: Contusion with 11%, Post procedural discomfort with 11%, Constipation with 11%, Rash with 6%, Nasopharyngitis with 6%.

Trial Design

2 Treatment Groups

Control
Denosumab

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.

Denosumab
Drug
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 year for reporting.

Who is running the study

Principal Investigator
B. L.
Prof. Brea Lipe, Associate Professor - Department of Medicine , Hematology/Oncology
University of Rochester

Closest Location

University of Rochester - Rochester, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Which means that they can handle taking calcium and vitamin D supplements every day. show original
At least 50% of the bone marrow is made up of plasma cells. show original
The patient meets the criteria for SMM as defined by the IMWG, based on the presence of an M-protein level of ≥3 g/dL or a BMPC level of >10% but less than 60%, along with normal organ and marrow function show original
to maintain bone health A person must have a vitamin D level ≥ 30 ng/mL after repletion in order to maintain bone health. show original
and patients with a history of viral hepatitis can enroll with a transiently increased AST(SGOT) Individuals diagnosed with Gilbert's syndrome can enroll in the study as long as their total bilirubin level is below 2.0 times the institutional upper limit of normal show original
Multiple myeloma should be considered in a patient with an increased uptake on PET-CT if there is evidence of underlying osteolytic bone destruction on the CT portion of the examination. show original
The text is saying that there is a deficiency in the immunoglobulin levels of ≥ 20%. show original
The patient had a serum calcium level of 2.1 mmol/L (8.4 mg/dL), which is within the reference range. show original
An abnormal free light chain ratio
The patient has an M-spike (a protein found in the blood) of ≥ 4 g/dL. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes smoldering multiple myeloma?

Add answer

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.

Unverified Answer

What is smoldering multiple myeloma?

Add answer

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.

Unverified Answer

Can smoldering multiple myeloma be cured?

Add answer

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.

Unverified Answer

What are common treatments for smoldering multiple myeloma?

Add answer

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.

Unverified Answer

What are the signs of smoldering multiple myeloma?

Add answer

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.

Unverified Answer

How many people get smoldering multiple myeloma a year in the United States?

Add answer

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.

Unverified Answer

Is denosumab safe for people?

Add answer

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.

Unverified Answer

Does denosumab improve quality of life for those with smoldering multiple myeloma?

Add answer

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.

Unverified Answer

What are the chances of developing smoldering multiple myeloma?

Add answer

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.

Unverified Answer

What are the latest developments in denosumab for therapeutic use?

Add answer

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.

Unverified Answer

What is denosumab?

Add answer

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.

Unverified Answer

How does denosumab work?

Add answer

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.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Smoldering Multiple Myeloma by sharing your contact details with the study coordinator.