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Lenalidomide and Dexamethasone (LEN plus DEX) Treatment in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (pts) and Risk of Second Primary Malignancies (SPM): Analysis of MM-009/010. Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009. MM-009/010 Study Designs.

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Dimopoulos ma et al proc asco 2011 abstract 8009

Lenalidomide and Dexamethasone (LEN plus DEX) Treatment in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (pts) and Risk of Second Primary Malignancies (SPM): Analysis of MM-009/010

Dimopoulos MA et al.

Proc ASCO 2011;Abstract 8009.


Mm 009 010 study designs
MM-009/010 Study Designs Relapsed/Refractory Multiple Myeloma (RRMM) Patients (pts) and Risk of Second Primary Malignancies (SPM): Analysis of MM-009/010

  • Analysis of pooled data from patients with relapsed/refractory multiple myeloma (RRMM) treated in 2 Phase III studies (MM-009) and (MM-010): N = 704

LEN 25 mg/d d1-21

Dex: 40 mg/d d1-4, 9-12, 17-20 1st 4 cycles;

40 mg/d d1-4 subsequent cycles

Continue

until

disease

progression

R

Placebo d1-28

Dex: 40 mg/d d1-4, 9-12, 17-20 1st 4 cycles;

40 mg/d d1-4 subsequent cycles

Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009.


Incidence rates for spm during active treatment phase safety population
Incidence Rates for SPM During Active Treatment Phase (Safety Population)

*Pts with >1 SPM counted once in the total

Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009.


Incidence rates of invasive spm during treatment and follow up
Incidence Rates of Invasive SPM* During Treatment and Follow-Up

Double-blind phase

Long-term follow-up only

SPM = 0

SPM = 2

IR: 1.91(95% CI 0.23-3.66)

817 PYtotal

PBO + Dex(n = 350)

IR: 0

218 PY

599 PY

SPM = 8

SPM = 0

Len + Dex(n = 353)

IR: 1.71(95% CI 0.86-3.43)

886 PYtotal

IR: 0

467 PY

419 PY

Person-Years

*Includes MDS and breast carcinoma in situ; excludes nonmelanoma skin cancers

With permission fromDimopoulos MA et al. Proc ASCO 2011;Abstract 8009.


Spm in rrmm mm 009 010 time to invasive spm treatment period
SPM in RRMM: MM-009/010 Follow-UpTime to Invasive SPM (Treatment Period)

Len + Dex

PBO + Dex

Hazard ratio: 1.445 (95% CI 0.294 7.09)

p = 0.649

Patients (%)

Time (months)

With permission fromDimopoulos MA et al. Proc ASCO 2011;Abstract 8009.


Len dex in rrmm overall survival up to unblinding
LEN + DEX in RRMM: Overall Survival (Up to Unblinding) Follow-Up

Hazard ratio: 0.607 (95% CI 0.459-0.803)

Patients (%)

Overall Survival (months)

With permission fromDimopoulos MA et al. Proc ASCO 2011;Abstract 8009.


Len dex overall survival including data after crossover
LEN + DEX Overall Survival Including Data After Crossover Follow-Up

Hazard ratio: 0.822 (95% CI 0.678-0.996)

Patients (%)

Overall Survival (months)

With permission fromDimopoulos MA et al. Proc ASCO 2011;Abstract 8009.


Conclusions
Conclusions Follow-Up

  • No difference in incidence rates of invasive SPMs in LEN + DEX arm versus PBO + DEX in MM-009/010

  • SPM incidence rates were low and similar to the background incidence among persons similarly aged in the general population

  • OS was significantly longer for patients who received LEN + DEX

    • Confirmed with long-term follow-up despite ~50% of patients in the PBO + DEX arm crossing over to receive LEN-based therapy

  • The overall benefit-risk profile of LEN in RRMM remains strongly positive

Dimopoulos MA et al. Proc ASCO 2011;Abstract 8009.


Investigator Commentary: The Incidence of SPMs After Follow-UpLong-Term Follow-Up of MM-009/010 in RRMM

Dr Niesvizky presented long-term follow-up of MM-009/010, which were the pivotal studies for approval of lenalidomide in relapsed/refractory multiple myeloma. The incidence of observed versus expected cancer was relatively similar, and many of these patients had already received high-dose melphalan and other treatments. So in this population there did not seem to be an increased risk of SPMs.

Lenalidomide has stem cell activity, and it is plausible that it can affect stem cells to a point that there may be development of SPMs, but it doesn’t seem to be a common phenomenon. When SPMs develop after lenalidomide, it happens after prolonged alkylator therapy or after high-dose alkylating agent exposure, such as in the transplant setting.

I initiate lenalidomide maintenance therapy for any patient who has not achieved a complete remission or in patients who have a high risk for relapse, even if they have achieved a CR. I delay lenalidomide maintenance for 5 to 6 months after transplant because I believe the “perfect storm” is to administer a drug that may be stem cell toxic at a time when the stem cells are beginning to proliferate and find their essential microenvironments.

Sergio Giralt, MD


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