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Induction Therapy For Multiple Myeloma: Two vs Three Drug Regimen and Role of Risk Stratification. Ravi Vij MD Associate Professor Section of BMT and Leukemia Washington University School of Medicine. 1989–1994. 1995–2000. 2001–2006. M. Trends in Overall Survival of MM. 1.0.

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induction therapy for multiple myeloma two vs three drug regimen and role of risk stratification

Induction Therapy For Multiple Myeloma:Two vs Three Drug Regimen and Role of Risk Stratification

Ravi Vij MD

Associate Professor

Section of BMT and Leukemia

Washington University School of Medicine

trends in overall survival of mm

1989–1994

1995–2000

2001–2006

M

Trends in Overall Survival of MM

1.0

Diagnosis period Median OS

1996–2006 45 months

1971–1996 30 months

(P<0.001)

0.8

2001–2006

OS, overall survival.

0.6

Survival

0.4

1971–1976

0.2

1977–1982

1983–1988

0

0

20

40

60

80

100

120

140

Time from diagnosis (Months)

Overall survival 1971–2006

Kumar SK, et al. Blood. 2008;111:2516-2520.

cr and mm
CR and MM
  • Is CR an adequate surrogate for OS?
  • Are all CRs as durable?
  • Should we strive for CR pre-transplant?
  • What is the role of HDCT for patients in CR pre-transplant?
cr associated with os prolongation in post induction and post transplant settings 1 3
CR associated with OS prolongation in post-induction and post-transplant settings1-3

Chemotherapy Alone

Chemotherapy and ASCT

Survival by response for 291 patients with MM (age <70 y) who received chemotherapy alone (left) and 375 who proceeded to ASCT (right) (CR vs PR or NR P<0.01)

1. Lahuerta et al. J Clin Oncol. 2008;26(3):5775-5782. 2.Alexanian et al. Bone Marrow Transplant. 2001;27:1037-1043. 3. Wang, et al. Bone Marrow Transplant. 2010;45(3):498-504.

slide5

Importance of CR in Elderly MM

> 65 yrs

> 75 yrs

Gay F et al. Blood. 2011;117(11):3025-3031)

slide6

Clearly not a transplant candidate

based on age, performance status

and comorbidity

Potential transplant

candidate

Conventional Therapy

Non-alkylator based

induction x 4 cycles

Stem cell harvest

Approach to Treatment of MM

bortezomib based induction prior to sct
Bortezomib-Based Induction Prior to SCT

*P <.001; †P =.001; ‡P =.05; §P =.02

GMMG= German Multiple Myeloma Group; SCT = stem cell transplant; CR = complete response; VGPR = very good partial response; PAD = bortezomib (V)/AD; T = thalidomide; VAD = vincristine, doxorubicin (A), dexamethasone (D); vTD = reduced-dose bortezomib.

Cavo M, et al. Lancet. 2010;376:2075-2085. Harousseau JL, et al. J ClinOncol. 2010;28:4621-4629. Sonneveld P, et al. ASH Annual Meeting Abstracts. 2010;116(21):40. http://web.educationalconcepts.net/Newsletter/MMY015AE1/MMY015AE1.pdf. Accessed July 17, 2012. Moreau P, et al. Blood. 2011;118: 5752-5758.

slide8

MPT vs MP in Elderly MM

Fayers PM et alBlood.2011;118(5):1239-1247

slide9

Overall Survival

Median survival:

MP 32.7 months (95% CI, 30.5-36.6 months)

MPT 39.3 months (95% CI, 35.6-44.6 months).

HR 0.83 (95% CI: 0.73-0.94)

P=0.004

slide10

MPR vs MP in Elderly MM

Palumbo et al. N Engl J Med 2012;366:1759-69.

mm 020 len low dose dex vs mpt in previously untreated mm
MM-020: Len + Low-dose Dexvs MPT in Previously Untreated MM
  • Lenalidomide 25 mg/day, days 1–21, every 28 days
  • Dexamethasone* 40 mg/day, days 1, 8, 15, 22, every 28 days

Until PD

  • Inclusion criteria
  • Previously untreated MM
  • Age  65 years or not a candidate for transplantation
  • No neuropathy of grade > 2
  • CICr > 30 ml/min

18 four-week cycles or until PD

  • Lenalidomide 25 mg/day, days 1–21, every 28 days
  • Dexamethasone* 40 mg/day, days 1, 8, 15, 22, every 28 days
  • Melphalan 0.25 mg/kg/day, days 1–4, every 42 days
  • Prednisone 2.0 mg/kg/day, days 1–4, every 42 days
  • Thalidomide* 200 mg/day, days 1–42, every 42 days

12 six-week cycles or until PD

N = 1,590

Centres in EU, Switzerland, USA and Canada

  • *In patients older than 75 years
  • Dexamethasone 20 mg/day
  • Thalidomide 100 mg/day
  • Melphalan 20 mg/kg/day

Protocol CC-5013-MM-020/IFM 07-01. 2007; data on file, Celgene Corporation

conclusions
Conclusions
  • Three drug induction regimen are associated with higher CR rates compared to two drug regimen.
  • In the transplant eligible population prospective trials have shown a higher CR rate and PFS for two drug regimen. Follow-up is too short for analyses of OS.
  • In the transplant ineligible population three drug regimes of thalidomide and bortezomib have a OS advantage compared with MP. Whether non-melphalan containing two drug regime may be equivalent is the subject of ongoing trials.
  • We have entered an era of risk stratification for deciding therapy. However no consensus has emerged on treatment paradigms.