IFM 2005-02 Study

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ASCO 2010
Lenalidomide maintenance after
transplantation for myeloma
(IFM 2005-02 Study)
Authors: Attal et al, ASCO 2010
Abstract: 8018
Reviewed by: Dr. Tom Kouroukis
Date posted: Jul 2 2010
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Background
• Lenalidomide is an active anti-myeloma agent in new
diagnosed or relapsed patients; it is more potent than
thalidomide
• Previous studies have shown benefits to thalidomide
maintenance post autologous stem cell transplantation in
patients with myeloma
• In Canada, practice has been to suggest thalidomide
maintenance following autologous stem cell
transplantation in newly diagnosed patients; barrier is
typically accessibility via the CANTAP program
• Lenalidomide is being tested as a maintenance therapy
post transplantation
Attal et al., ASCO 2010, abstract 8018
www.OncologyEducation.ca
IFM 2005-02 Study
• Patients post single autologous transplant for multiple
myeloma, age less than 65 years
• Most patients were treated with induction consisting of
VAD or bortezomib/dexamethasone
• Received consolidation with lenalidomide 25 mg/day x
21 days, monthly for 2 months followed by randomization
to either:
– Lenalidomide 10-15 mg/day until relapse, or
– Placebo
• PFS was the main outcome
Attal et al., ASCO 2010, abstract 8018
www.OncologyEducation.ca
IFM 2005-02 Study
• This abstract represents the first pre-planned interim
analysis
• The DSMB recommended unblinding the study due to
superiority of the lenalidomide arm
• With a median f/u of 24 months, 614 patients were
randomized
• Baseline patient characteristics were similar
Attal et al., ASCO 2010, abstract 8018
www.OncologyEducation.ca
IFM 2005-02 Study
• Consolidation improved response rate post transplant by
20%
• 3 year PFS was 68% vs. 35% in favour of lenalidomide
maintenance (HR 0.46, P<0.000001)
• 2 year OS was similar between both arms
• Conclusions: lenalidomide maintenance post autologous
stem cell transplant in myeloma improves PFS
Attal et al., ASCO 2010, abstract 8018
www.OncologyEducation.ca
BOTTOM-LINE FOR
CANADIAN MEDICAL ONCOLOGISTS
• Currently lenalidomide is approved and funded for use in
relapsed myeloma, after at least one prior therapy, in
combination with dexamethasone
• Thalidomide has no official Health Canada approval yet,
but has been used through Special Access as
maintenance post autologous stem cell transplant in
myeloma
• Thalidomide does have toxicities including neuropathy
which may limit its long term use
Attal et al., ASCO 2010, abstract 8018
www.OncologyEducation.ca
BOTTOM-LINE FOR
CANADIAN MEDICAL ONCOLOGISTS
• Lenalidomide is associated with less neuropathy but can
be associated with myelosuppression over time
• We don’t have comparative data between the two agents
in the maintenance setting
• Lenalidomide, when approved, will be an attractive
option for maintenance post transplantation
• The final report from this study may tell us how many
patients in the placebo group crossed over to receive
lenalidomide maintenance; and whether there is any
data regarding patients who received treatment with
lenalidomide for relapse compared to those who
received it for maintenance
Attal et al., ASCO 2010, abstract 8018
www.OncologyEducation.ca
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