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Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma 	 Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myelom
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Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myelom

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    • 1. Scottsdale, Arizona Rochester, Minnesota Jacksonville, Florida Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma Robert A. Kyle, MD Professor of Medicine Mayo Clinic
    • 2. MGUS Olmsted County MN
      • Criteria
      • Serum M-spike < 3.0 g/dL
      • Bone marrow plasma cells <10% if done
      • No evidence of other B-cell disorders
      • No end organ damage
    • 3. MGUS OLMSTED COUNTY, MN
      • RESULTS
      • Olmsted County Residents > 50 years; 28,038
      • Serum samples obtained from population: 77%
      Kyle et al., New Engl J Med, 2006, 354:1362
    • 4. MGUS Olmsted County MN CP1118008-35 Age No. No. % 50 – 59 8,373 141 1.7 60 – 69 6,019 178 3.0 70 – 79 4,508 205 4.6 ≥ 80 2,563 170 6.6 Total 21,463 694 3.2 ≥ 70 7,071 375 5.3 M-protein Kyle et al., New Engl J Med, 2006, 354:1362
    • 5. Age (yr) Prevalence of MGUS (%) Prevalence of MGUS According to Age Kyle et al., New Engl J Med, 2006, 354:1362
    • 6. MGUS in African Americans
      • White African American
      • N Subjects 3,250,107 749,754
      • MGUS N, % 1,312 (.40%) 734 (.98%)
      • MM at 10 yrs 15% 17%
      • Langren, et al., Blood, 107:904, 2006
    • 7. MGUS SE Minnesota Jan 1, 1960-Dec 31, 1994 CP1118008-24 Male (%) 54 Age (med years) 72 <40 years (%) 1.7 M-spike (g/dL-med) 1.2 n=1,384 Kyle, et al., New Engl J Med, 346:564, 2002
    • 8.
      • Relative Risk of Progression
      • Obs Exp* RR
      • Multiple Myeloma 75 3 25
      • Lymphoma, IgM 19 7.8 2.4
      • Amyloidosis 10 1.2 8.4
      • Macroglobulinemia 7 0.2 46
      • CLL 3 3.5 0.9
      • Plasmacytoma 1 0.1 8.5
      • Total 115 15.8 7.3
      • * Iowa SEER Registry
      MGUS SE MINNESOTA Kyle, et al., New Engl J Med, 346:564, 2002
    • 9. MGUS SE Minnesota 1960-1994 n=1,384 12% 25% 30% First progression Full progression 10% 21% 26% Cumulative probability (%) Years 1,384 Patients at risk (no.) 867 423 177 56 17 CP1022686-6 Kyle, et al., New Engl J Med, 346:564, 2002
    • 10. Full Progression or Death CP971723- 6 Cumulative incidence (%) Years 6% Progression Death 10% 11% 53% 72% 76% Kyle, et al., New Engl J Med, 346:564, 2002
    • 11. Relative Risk of Full Progression by Serum M-Spike Size Serum m-spike value CP999081-2 Relative risk of full progression Probability of full progression at 20 years (%) 13.6 15.6 41.2 48.8 24.6 64 Kyle, et al., New Engl J Med, 346:564, 2002 0.5 1.0 1.5 2.0 2.5 3.0 13.6 25 50 65 3 9 5 7 1
    • 12. MGUS and Free Light Chain (FLC) Rajkumar, et al., Blood; 106:1148, 2005 18 37 10.1 226 2 risk factors, abn Competing risk Absolute 27 10 2 58 20.8 53 3 risk factors, abn 21 5.4 420 1 risk factor, abn 5 1 449 M-protein < 1.5 g/dl, IgG, Normal FLC Risk of Prog 20 yr % RR 95% CI N
    • 13. Smoldering Multiple Myeloma
      • Serum M-spike ≥ 3 g/dl
      • and
      • Bone marrow plasma cells ≥ 10%
      • No end organ damage
      • Kyle RA and Greipp PR, NEJM, 302:1347, 1980.
    • 14. Smoldering Multiple Myeloma
      • Mayo Clinic 1970 – 1994
      • N %
      • Serum M-protein ≥ 3 g/dl
      • and 113 38
      • Bone marrow plasma cells ≥ 10%
      • Serum M-protein < 3 g/dl
      • and 158 52
      • Bone marrow plasma cells ≥ 10%
      • Serum M-protein ≥ 3 g/dl
      • and 30 10
      • Bone marrow plasma cells < 10%
      • TOTAL 301 100
    • 15. Smoldering Multiple Myeloma
      • Time to progression Median years
      • Serum M-spike ≥ 3 Bone marrow plasma 2.2 cells ≥ 10
      • Serum M-spike < 3 Bone marrow plasma 7.8 cells ≥ 10
      • Serum M-spike ≥ 3 Bone marrow plasma 19 cells < 10 Total (N = 301) p= <0.001 5.5
    • 16. years from diagnosis percent 0 5 10 15 20 25 0 20 40 60 80 100 Progression to Multiple Myeloma or Amyloid 51% 66% 73% 78%
    • 17. years from diagnosis percent 0 5 10 15 20 25 0 20 40 60 80 100 Progression to MM or AL 14% 32% 39% 54% 43% 63% 70% 70% 70% 78% 88% 4% 10% 16% 21% M-spike>=3 & BMPC>=10 M-spike< 3 & BMPC>=10 M-spike>=3 & BMPC<10 MGUS years from diagnosis percent 0 5 10 15 20 25 0 20 40 60 80 100 Progression to MM or AL 14% 32% 39% 54% 43% 63% 70% 70% 70% 78% 88% 4% 10% 16% 21% M-spike>=3 & BMPC>=10 M-spike< 3 & BMPC>=10 M-spike>=3 & BMPC<10 MGUS years from diagnosis percent 0 5 10 15 20 25 0 20 40 60 80 100 Progression to MM or AL 14% 32% 39% 54% 43% 63% 70% 70% 70% 78% 88% 4% 10% 16% 21% M-spike>=3 & BMPC>=10 M-spike< 3 & BMPC>=10 M-spike>=3 & BMPC<10 MGUS years from diagnosis percent 0 5 10 15 20 25 0 20 40 60 80 100 Progression to MM or AL 14% 32% 39% 54% 43% 63% 70% 70% 70% 78% 88% 4% 10% 16% 21% M-spike>=3 & BMPC>=10 M-spike< 3 & BMPC>=10 M-spike>=3 & BMPC<10 MGUS
    • 18. MGUS and SMM
      • Standard of Care:
      • Defer Treatment Until End Organ Damage
      • C Hyper c alcemia
      • R R enal Insufficiency
      • A A nemia
      • B B one disease
    • 19. MGUS and SMM
      • Therapy justified only if preventative strategy prolongs survival
    • 20. MGUS/SMM Subcommittee
      • Ann Farrell, M.D. FDA
      • Rafael Fonseca, M.D. Mayo
      • Geraldine P. Schechter, M.D. VA
      • Robert A. Kyle, M.D. Mayo
    • 21. MGUS Question
      • How often should the patient be monitored?
      • Should “high risk” MGUS be treated?
      • Why is MGUS increased in African-Americans?
    • 22. SMM Question
      • Should SMM have both M spike ≥ 3g/dl and plasma cells ≥ 10%.
      • Should SMM be treated?
      • Does reduction of M spike and plasma cells delay progression?

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