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First Published Stage II Results On Pomalidomide

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First Published Stage II Results On Pomalidomide

Several members of one to the myeloma support groups I attend are part of the new Stage III trial which immediately followed this Stage II trial sponsored by Mayo Clinic. Apparently, Stage III trial is going even better than results shared in this paper! Participants I know in this Stillwater, Minnesota group are doing fabulously! Most myeloma docs I have spoken with expect Pomalidomide to soon be the oral novel agent of choice for re-lapsing myeloma patients. Not to dampen my (or your!)enthusiasm for this new drug, but I should add both patients I personally know in trial have done well in the past, one going seven or eight years in CR following her first transplant, the other to yet receive a SCT. My guess is both would do fine on Revlimid as well. Both also use very low dex as part of the study.

Pomalidomide (CC4047) plus low-dose dexamethasone as therapy for relapsed multiple myeloma.
Lacy MQ, Hayman SR, Gertz MA, Dispenzieri A, Buadi F, Kumar S, Greipp PR, Lust JA, Russell SJ, Dingli D, Kyle RA, Fonseca R, Bergsagel PL, Roy V, Mikhael JR, Stewart AK, Laumann K, Allred JB, Mandrekar SJ, Rajkumar SV.

Division of Hematology, Mayo Clinic College of Medicine, Rochester, MN 55905, USA. lacy.martha@mayo.edu

PURPOSE: Thalidomide and lenalidomide are immunomodulatory drugs (IMiDs) that produce high remission rates in the treatment of multiple myeloma. Pomalidomide is a new IMiD with high in vitro potency. We report, to our knowledge, the first phase II trial of pomalidomide administered in combination with low-dose dexamethasone for the treatment of relapsed or refractory multiple myeloma. PATIENTS AND METHODS: Pomalidomide was administered orally at a dose of 2 mg daily on days 1 through 28 of a 28-day cycle. Dexamethasone 40 mg daily was administered orally on days 1, 8, 15, and 22 of each cycle. Responses were recorded using the criteria of the International Myeloma Working Group. RESULTS: Sixty patients were enrolled. Thirty-eight patients (63%) achieved confirmed response including complete response in three patients (5%), very good partial response in 17 patients (28%), and partial response in 18 patients (30%). Responses were seen in 40% of lenalidomide-refractory patients, 37% of thalidomide-refractory patients, and 60% of bortezomib-refractory patients. Responses were seen in 74% of patients with high-risk cytogenetic or molecular markers. Toxicity consisted primarily of myelosuppression. Grade 3 or 4 hematologic toxicity consisted of anemia (5%), thrombocytopenia (3%), and neutropenia (32%). One patient (1.6%) had a thromboembolic event. The median progression-free survival time was 11.6 months and was not significantly different in patients with high-risk disease compared with patients with standard-risk disease. CONCLUSION: The combination of pomalidomide and low-dose dexamethasone is extremely active in the treatment of relapsed multiple myeloma, including high response rates in patients refractory to other novel agents.

PMID: 19720894 [PubMed – in process]

Feel good, keep smiling and stay hopeful! This is exciting stuff! Pat