Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma.

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.

• Authors: Laurent Garderet, Frederique Kuhnowski, Benoit Berge, Murielle Roussel, Martine Escoffre-Barbe, Ingrid Lafon, Thierry Facon, Xavier Leleu, Lionel Karlin, Aurore Perrot, Philippe Moreau, Gerald Marit, Anne-Marie Stoppa, Bruno Royer, Carine Chaleteix, Mourad Tiab, Carla Araujo, Pascal Lenain, Margaret Macro, Eric Voog, Lofti Benboubker, Olivier Allangba, Eric Jourdan, Frederique Orsini-Piocelle, Sabine Brechignac, Jean-Richard Eveillard, Karim Belhadj, Marc Wetterwald, Brigitte Pegourie, Arnaud Jaccard, Jean-Claude Eisenmann, Sylvie Glaisner, Mohamad Mohty, Cyrille Hulin, Herve Avet Loiseau, Claire Mathiot, Michel Attal
• Journal: Blood (Blood) Vol. 132 Issue 24 Pg. 2555-2563 (12 13 2018) ISSN: 1528-0020 [Electronic] United States
• PMID: 30282798 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2018 by The American Society of Hematology.

Chemical References

• Thalidomide
• Dexamethasone
• Cyclophosphamide
• pomalidomide

Topics

• Administration, Oral
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Cyclophosphamide (administration & dosage, adverse effects)
• Dexamethasone (administration & dosage, adverse effects)
• Disease-Free Survival
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Multiple Myeloma (drug therapy, mortality)
• Recurrence
• Survival Rate
• Thalidomide (administration & dosage, adverse effects, analogs & derivatives)