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Blood. 2018 Dec 13;132(24):2555-2563. doi: 10.1182/blood-2018-07-863829. Epub 2018 Oct 3.

Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma.

Author information

1
Proliferation and Differentiation of Stem Cells, INSERM, Unité Mixte de Recherche (UMR)_S 938, Paris, France.
2
Département d'Hématologie et de Thérapie Cellulaire, Assistance Publique des Hôpitaux de Paris, Hôpital Saint Antoine, Paris, France.
3
Sorbonne Université, Paris, France.
4
Institut Curie, Paris, France.
5
Euraxi, Paris, France.
6
Centre Hospitalier Universitaire, Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.
7
Centre Hospitalier Universitaire, Rennes, France.
8
Centre Hospitalier Universitaire, Dijon, France.
9
Maladies du Sang, Hôpital Claude Huriez, Centre Hospitalier Régional Universitaire Lille, Lille, France.
10
Hospices Civils de Lyon, Pierre Benite Cedex, France.
11
Centre Hospitalier Universitaire, Vandoeuvre Les Nancy, France.
12
Centre Hospitalier Universitaire Hôtel Dieu, Nantes, France.
13
Centre Hospitalier Universitaire, Bordeaux, France.
14
Department of Hematology, Institut Paoli Calmettes, Marseille, France.
15
Centre Hospitalier Universitaire, Amiens, France.
16
Centre Hospitalier Universitaire, Clermont Ferrand, France.
17
Hopital de La Roche sur Yon, La Roche sur Yon, France.
18
Centre Hospitalier de la Côte Basque, Bayonne, France.
19
Centre Henri Becquerel, Rouen, France.
20
Centre Hospitalier Universitaire, Caen, France.
21
Centre Hospitalier de Le Mans, Le Mans, France.
22
Centre Hospitalier Universitaire, Hôpital Bretonneau, Tours, France.
23
Centre Hospitalier de Saint Brieuc, Saint Brieuc, France.
24
Centre Hospitalier Universitaire, Nîmes, France.
25
Centre Hospitalier de la région d'Annecy, Pringy, France.
26
Hôpital Avicenne, Bobigny, France.
27
Hôpital Morvan, Brest, France.
28
Centre Hospitalier Universitaire Henri Mondor, Créteil, France.
29
Centre Hospitalier Général, Dunkerque, France.
30
Centre Hospitalier Régional et Universitaire, Grenoble, France.
31
Centre Hospitalier Universitaire, Limoges, France.
32
Hôpital Emile Muller, Mulhouse, France.
33
Hôpital René Huguenin, Saint Cloud, France; and.
34
Hôpital Rangueil, Toulouse, France.

Abstract

It is important to have an effective therapy for patients with multiple myeloma (MM) at first relapse, particularly if an autologous stem cell transplant (ASCT) is considered at this stage. This multicenter, phase 2 trial evaluated the efficacy and safety of weekly oral pomalidomide-cyclophosphamide-dexamethasone (PCD) in patients with MM in first relapse after treatment with lenalidomide-bortezomib-dexamethasone (RVD). All patients had received RVD as induction and consolidation therapy, plus lenalidomide maintenance for 1 year (arm A). Half had also received an ASCT after induction (arm B). At MM relapse, all patients received 4 oral cycles of pomalidomide 4 mg (days 1-21), cyclophosphamide 300 mg (days 1, 8, 15, and 22), and dexamethasone 40 mg (days 1-4 and days 15-18 of a 28-day cycle; PCD). Responding patients in arm A underwent ASCT and received 2 additional cycles of PCD, whereas those in arm B received 5 cycles of PCD. All patients received pomalidomide-dexamethasone maintenance until disease progression. Primary end point was partial remission or better after the initial 4 cycles of PCD. Responses were obtained in 82/97 (85%) patients evaluated: complete remission (n = 1; 1%), very good partial remission (n = 32; 33%), and partial remission (n = 49; 51%). Three patients (3%) had stable disease, and 6 (6%) had disease progression (6 response failures). Forty-five (94%) of the 48 patients in arm A underwent planned ASCT. PCD was effective therapy after first relapse with RVD. After 4 cycles, the rate of partial remission or better was 85%, and 94% of planned ASCTs were performed. Toxicity was mostly hematologic and manageable. This trial was registered at www.clinicaltrials.gov as #NCT02244125.

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