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IFM 99-06

Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial

N = 447NCT00367185

Population
Previously untreated patients with multiple myeloma aged 65 to 75 years.
Design
Randomised trial between May 22, 2000 and Aug 8, 2005 in 447 previously untreated patients with multiple myeloma aged 65 to 75 years, assigned to melphalan and prednisone (MP), melphalan and prednisone plus thalidomide (MPT), or reduced-intensity stem cell transplantation using melphalan 100 mg/m2 (MEL100). The primary endpoint was overall survival; analysis was by intention to treat.
Primary endpoint
OS
Arms
  • Melphalan plus prednisone (control, n = 196): Melphalan and prednisone
  • Melphalan, prednisone plus thalidomide (experimental, n = 125): Melphalan and prednisone plus thalidomide
  • Reduced-intensity transplant (MEL100) (experimental, n = 126): Reduced-intensity stem cell transplantation using melphalan 100 mg/m2
People
Facon T
OSHR 0.59 (95% CI 0.46–0.81)Δ median OS+18.4 monthsOSHR 0.69 (95% CI 0.49–0.96)OSHR 0.86 (95% CI 0.65–1.15)Δ median OS+5.1 months
Show the numbers
Results reported for IFM 99-06
EndpointAnalysisMelphalan, prednisone plus thalidomide / Reduced-intensity transplant (MEL100)Melphalan plus prednisoneEffect
OSIntention to treatprimarymedian follow-up 51.5 monthsFacon 2007median 51.6 monthsmedian 33.2 monthsHR 0.59 (95% CI 0.46–0.81)P=0.0006Hazard ratio is MPT versus MP. The ranges quoted beside the medians in the abstract (MP 13.8-54.8; MPT 26.6-not reached) are not confidence intervals (the abstract does not label them; they follow its interquartile range for follow-up).
OSIntention to treatprimarymedian follow-up 51.5 monthsFacon 2007median 38.3 months—HR 0.69 (95% CI 0.49–0.96)P=0.027Hazard ratio is MPT versus MEL100. The range beside the MEL100 median in the abstract (13.0-61.6) is not a confidence interval (the abstract does not label it).
OSIntention to treatprimarymedian follow-up 51.5 monthsFacon 2007median 38.3 monthsmedian 33.2 monthsHR 0.86 (95% CI 0.65–1.15)P=0.32Hazard ratio is MEL100 versus MP; no difference was seen.
Results reported for IFM 99-06
EndpointAnalysisMelphalan, prednisone plus thalidomide / Reduced-intensity transplant (MEL100)Melphalan plus prednisoneEffect
OSIntention to treatprimarymedian follow-up 51.5 monthsFacon 2007median 51.6 monthsmedian 33.2 monthsHR 0.59 (95% CI 0.46–0.81)P=0.0006Hazard ratio is MPT versus MP. The ranges quoted beside the medians in the abstract (MP 13.8-54.8; MPT 26.6-not reached) are not confidence intervals (the abstract does not label them; they follow its interquartile range for follow-up).
OSIntention to treatprimarymedian follow-up 51.5 monthsFacon 2007median 38.3 months—HR 0.69 (95% CI 0.49–0.96)P=0.027Hazard ratio is MPT versus MEL100. The range beside the MEL100 median in the abstract (13.0-61.6) is not a confidence interval (the abstract does not label it).
OSIntention to treatprimarymedian follow-up 51.5 monthsFacon 2007median 38.3 monthsmedian 33.2 monthsHR 0.86 (95% CI 0.65–1.15)P=0.32Hazard ratio is MEL100 versus MP; no difference was seen.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSOSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.590.46–0.81
OS0.690.49–0.96
OS0.860.65–1.15
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080100120Months (modelled)
  • Melphalan plus prednisone (control)
  • Melphalan, prednisone plus thalidomide (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsMelphalan plus prednisoneMelphalan, prednisone plus thalidomide
0100.0%100.0%
3251.3%65.1%
6525.7%41.8%
9713.2%27.2%
1296.8%17.7%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080100120Months (modelled)
  • Reduced-intensity transplant (MEL100) (experimental)
  • Melphalan, prednisone plus thalidomide (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsReduced-intensity transplant (MEL100)Melphalan, prednisone plus thalidomide
0100.0%100.0%
3256.0%65.1%
6530.8%41.8%
9717.3%27.2%
1299.7%17.7%
Primary publication: Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, et al. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007;370(9594):1209-18. PubMedDOI

Appears in

Sources

  1. Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, et al. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007;370(9594):1209-18.

    PubMedDOI