Observational studyMultiple myeloma

Clinical Course and Prognosis of Smoldering (Asymptomatic) Multiple Myeloma

N Engl J Med · 2007276 patients
Kyle RA, Remstein ED, Therneau TM, Dispenzieri A, Kurtin PJ, Hodnefield JM, et al. N Engl J Med. 2007. 356:2582-2590
Study type
Observational study
Design
Single-centre retrospective cohort study (review of the medical records of Mayo Clinic patients)
Sample size
276 patients
Source
N Engl J Med · 2007

In plain words

Smouldering multiple myeloma is a condition in which the plasma cells in the bone marrow are abnormal, but the person does not yet have any symptoms. In this study, about 6 out of every 10 patients developed myeloma with symptoms or amyloidosis during follow-up, and the risk was highest in the first 5 years after diagnosis. The proportion of plasma cells in the bone marrow and the amount of monoclonal protein in the blood help predict the chance that the disease will progress.

Key results

276 patients
Number of patients meeting the criteria over the 26-year period
2131 person-years of cumulative follow-up
163 patients (59%)
Progression to symptomatic multiple myeloma or amyloidosis
10% per year
Risk of progression in the first 5 years
About 3% per year
Risk of progression in the next 5 years
1% per year
Risk of progression in the last 10 years
73%
Cumulative probability of progression at 15 years
Three distinct prognostic groups
Risk stratification model
Based on the combination of the percentage of bone marrow plasma cells and the size of the serum monoclonal protein

Treatment arms and regimens

1All patients with smouldering multiple myeloma

This is an observational study and no specific treatment intervention was evaluated. Patients were followed over the course of the disease. Dose details in the full text of the paper.

Source of the regimen details: Abstract of the paper

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

All patients seen at Mayo Clinic between 1970 and 1995 who met the International Myeloma Working Group criteria for smouldering (asymptomatic) multiple myeloma.

Endpoints

Progression to symptomatic multiple myeloma or amyloidosis, and identification of risk factors associated with progression and outcome; factors examined included the size and type of the serum monoclonal protein, the presence of urinary light chains, the extent and pattern of bone marrow involvement and reduction of uninvolved immunoglobulins.

Safety and side effects

This was an observational study, and no safety data or adverse effects of a treatment intervention are reported in the abstract.

Clinical significance and place in guidelines

This study gives a clear picture of the natural history and time pattern of progression risk in smouldering myeloma and shows that the proportion of bone marrow plasma cells and the size of the serum monoclonal protein can be used for risk stratification. How these findings are applied in current clinical guidelines (including decisions on surveillance or treatment) should be checked in up-to-date guidelines; the abstract does not comment on this.

Limitations

Based on the abstract: the study was a retrospective review of records from a single centre (Mayo Clinic) and no treatment intervention was compared. Other limitations should be checked in the full text of the paper.

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.