Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide: comparison of 2 dosing strategies in dual-refractory disease.

Blood 2011 Sep 20;118(11):2970-5. Epub 2011 Jun 20.

Mayo Clinic College of Medicine, Rochester, MN, USA.

Pomalidomide at doses of 2 or 4 mg/d has demonstrated excellent activity in patients with multiple myeloma (MM). We opened 2 sequential phase 2 trials using the pomalidomide with weekly dexamethasone (Pom/dex) regimen at differing doses to study the efficacy of this regimen in patients who have failed both lenalidomide and bortezomib. Pomalidomide was given orally 2 or 4 mg daily with dexamethasone 40 mg weekly. Thirty-five patients were enrolled in each cohort. Confirmed responses in the 2-mg cohort consisted of very good partial response (VGPR) in 5 (14%), partial response (PR) in 4 (11%), minor response (MR) in 8 (23%) for an overall response rate of 49%. In the 4-mg cohort, confirmed responses consisted of complete response (CR) in 1 (3%), VGPR in 3 (9%), PR in 6 (17%), MR in 5 (14%) for an overall response rate of 43%. Overall survival at 6 months is 78% and 67% in the 2- and 4-mg cohort, respectively. Myelosuppression was the most common toxicity. This nonrandomized data suggests no advantage for 4 mg over the 2 mg daily. Pomalidomide overcomes resistance in myeloma refractory to both lenalidomide and bortezomib. This trial is registered at http://ClinicalTrials.gov, number NCT00558896.

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http://dx.doi.org/10.1182/blood-2011-04-348896DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3291492PMC
September 2011
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References

(Supplied by CrossRef)
A phase 1/2 multi-center, randomized, open label dose escalation study to determine the maximum tolerated dose, safety, and efficacy of pomalidomide alone or in combination with low-dose dexamethasone in patients with relapsed and refractory multiple myeloma who have received prior treatment that includes lenalidomide and bortezomib [abstract].
Richardson et al.
Blood (ASH Annual Meeting Abstracts) 2010
Phase 2 study of 2 modalities of pomalidomide (CC4047) plus low-dose dexamethasone as therapy for relapsed multiple myeloma. IFM 2009-02 [abstract].
Leleu et al.
Blood (ASH Annual Meeting Abstracts) 2010
Natural history of multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter International Myeloma Working Group Study [abstract].
Kumar et al.
Blood (ASH Annual Meeting Abstracts) 2009

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