The benefit of combining a third agent with pomalidomide and dexamethasone has also been shown in a randomized, phase 2 trial of pomalidomide and dexamethasone with or without cyclophosphamide, in . This study is being done to learn more about the drug, pomalidomide and to gather data on its safety and side effects when used in combination with commercially available cyclophosphamide and dexamethasone. 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. When cyclophosphamide was added to pomalidomide-prednisone, hematologic toxicity was comparable to that observed with pomalidomide-dexamethasone. 21. Pomalidomide is both a targeted therapy drug and an immunotherapy drug. This randomized phase I/II trial studies the side effects and best dose of pomalidomide and ixazomib when given together with dexamethasone and to see how well pomalidomide and dexamethasone with or without ixazomib works in treating patients with multiple myeloma that has come back. 25 In another pomalidomide, cyclophosphamide-prednisone study, patients who had 3 lines of prior therapy had an ORR of 51 . NCCN guidelines also endorse the use of either carfilzomib or cyclophosphamide together with pomalidomide and dexamethasone in this population . 15 and 22 . In treatment ARM A patients will receive daratumumab, cyclophosphamide, dexamethasone and pomalidomide as per the following schedule: - Daratumumab, IV, at 16 mg/kg, or Daratumumab, SC, at 1800 mg on days 1, 8, 15 and 22 for Cycles 1 and 2, on Days 1 and 15 for Cycles 3-6, and Day 1 of each cycle for Cycle 7 and beyond for each 28-day cycle. Other combinations with second generation agents are being investigated to improve those outcomes: Pomalidomide (P)-based P- cyclophosphamide- dexamethasone 12 The lower response rate obtained with PomCiDex compared to PVd or IsaPd may reflect the mechanism of action of cyclophosphamide . Mark TM, Rodriguez M, Shah M, Quinn R, Campbell J, Abdullah R, Pearse RN, Zafar F, Pekle Maintenance Lenalidomide after Autologous Stem Cell Transplant - Multiple Myeloma Protocol V1.0. 2013 Oct;14(11):1055 -1066. The addition of cyclophosphamide to patients presenting a suboptimal response to pomalidomide and dexamethasone has also been evaluated in the PERSPECTIVE phase 2 trial [75]. 2016;127:2561-2568. This study aimed to assess the efficacy and safety of pomalidomide, cyclophosphamide, and dexamethasone (PCd) in elderly patients with RRMM. 2016;128(22):abstract 4520. Pomalidomide plus low versus high-dose -dose dexamethasone dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study Median progression-free and overall survival were 7.6 and 12.6 months, respectively, which compares favorably with other triplets in the same setting. 1.1 Pomalidomide, in combination with low‑dose dexamethasone, is recommended as an option for treating multiple myeloma in adults at third or subsequent relapse; that is, after 3 previous treatments including both lenalidomide and bortezomib, only when the company provides pomalidomide with the discount agreed in the patient access scheme. reported a randomized phase II trial including 70 patients where pomalidomide + dexamethasone was compared to pomalidomide, cyclophosphamide, and dexamethasone showing a significant increase in ORR, median PFS, and median OS . Myeloma - Dexamethasone (40)-Pomalidomide Pomalidomide 4mg once a day 1-21 (inclusive) Oral Dexamethasone 40mg 1, 8 15 and 22 Oral Dose Information • Pomalidomide is available as 1mg, 2mg, 3mg and 4mg hard capsules. (e.g. Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma . Highest treatment efficacy in patients with refractory myeloma may be achieved with regimens combining novel agents and alkylating agents. At first relapse, participants received PCD in 28-day cycles, consisting of: pomalidomide 4 mg on days 1-21; cyclophosphamide 300 mg on days 1, 8, 15, and 22; dexamethasone 40 mg on days 1-4 and 15-18 dosing schedule in combination with lenalidomide or pomalidomide (4-week cycle) and low-dose dexamethasone and for monotherapy: -Weeks 1 to 8: 16 mg/kg IV weekly (total of 8 doses) -Weeks 9 to 24: 16 mg/kg IV every 2 weeks (total of 8 doses); first dose of the every-2-week dosing schedule is given at Week 9 With an estimated additional 10 months of remission, pomalidomide could be a major development. Cost: ~ $10,000 per cycle "How this cost is calculated". EudraCT Number: 2006-007082-36 Sponsor Protocol Number: RV178 Start Date *: 2007-10-16: Sponsor Name: Hellenic Oncology Cooperative Group Full Title: A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis Medical condition: Primary (AL) amyloidosis in untreated patients or patientsw who have . Cost: ~ $6,080 per cycle "How this cost is calculated". In 2013 Pomalidomide (Pom) in combination with dexamethasone (dex) was approved for the treatment of RRMM. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. A Comparison of Salvage Infusional Chemotherapy Regimens for Recurrent/Refractory Multiple Myeloma Patrick T. Griffin, MD1; Viet Q. Ho, PharmD, BCOP2; William Fulp, MS3; Taiga Nishihori, MD4; Kenneth H. Shain, MD, PhD1; Melissa Alsina, MD4; and Rachid C. Baz, MD1 BACKGROUND: Despite the impact of proteasome inhibitors and immunomodulatory agents, infusional chemotherapy regimens con- The addition of cyclophosphamide to pomalidomide and dexamethasone was shown to be effective in other trials. . Pomalidomide can: help the immune system attack and destroy cancer cells ( immune system modulator) kill or stop the growth of cancer cells ( cancer growth inhibitor) block the development of new blood vessels which cancer cells need to . Induction regimens in multiple myeloma (MM) utilizing bortezomib in combination with dexamethasone and cyclophosphamide or lenalidomide have proven effective in transplant-eligible patients, resulting in partial response (PR) rates of more than 90% and approximately one third of patients entering complete response (CR) prior to transplantation (Khan et al, 2012). All drugs were administered orally. Patients were randomized 1:1 to receive up to eight 3-week cycles of bortezomib (1.3 mg/m2) and dexamethasone (20 mg; VD; n = 48) or bortezomib-dexamethasone plus . Treatment of patients showing an isolated biochemical relapse at disease progression with combination of Pomalidomide, Ixazomib, Dexamethasone plus Cyclophosphamide. Drug administration. 1 Recommendations. Pomalidomide is a third generation immunomodulatory drug which in combination with dexamethasone, has been shown to be active in relapsed/refractory multiple myeloma. The pivotal, multicenter, open-label, randomized phase 3 trial MM-003 compared pomalidomide + low-dose dexamethasone vs high-dose dexamethasone in 455 patients with refractory or relapsed and refractory multiple myeloma after failure of bortezomib and . Lenalidomide & Dexamethasone Multiple Myeloma Protocol V1. et al. The cost displayed on the protocol is intended as rudimentary guide only for the Australian context. Randomized multicenter phase 2 study of pomalidomide, cyclophosphamide, and dexamethasone in relapsed refractory myeloma. Low dose corticosteroids consisted of dexamethasone 6 mg or prednisone 30 mg every other day or another equivalent corticosteroid dose. Additional cyclophosphamide (50 mg) was optional, but was given to 95% of patients in the control arm. Recently, a randomized study of Pomalidomide and dexamethasone conducted in The median PFS here reported of 7.58 months is comparable to that of PVd or DVd, and is also comparable to the combination of pomalidomide, cyclophosphamide, and dexamethasone reported in a phase 2 randomized study. It is quite possible that the universities get these drugs for free to conduct such studies to test the effectiveness of these drugs. 2019 Dec 7. The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the studied population using International Myeloma Working Group (IMWG) response criteria [Rajkumar, 2011]. Methods: Between July 2013 and July 2018, 76 . Also the protocol study / research you are participating in has its own restrictions on the participants. The new treatment is as follows: Every day for 21 days per month, 4 mg capsule of poma­lido­mide (Pomalyst, Imnovid). Larocca A, Montefusco V, Bringhen S, et al. If stem cells required after this regimen consider no more than 4 cycles prior to harvest. Background: We retrospectively analysed relapsed/refractory MM (RRMM) patients treated with pomalidomide and dexamethasone (PomaD) either in real life, or previously enrolled in an interventional (STRATUS, MM-010) or currently enrolled in an observational study (MM-015) to provide further insights on safety and tolerability and clinical efficacy. Pomalidomide is available as 1 mg, 2 mg, 3 mg and 4 mg capsules. Purpose Thalidomide and lenalidomide are immunomodulatory drugs (IMiDs) that produce high remission rates in the treatment of multiple myeloma. Miguel JS. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the immune system in different ways . 30,31 Toxicity was mostly hematologic, and one-third of patients experienced a decrease in dose of either pomalidomide or cyclophosphamide. BC Cancer Protocol Summary UMYLDREL Page 1 of 7 Activated: 1 Dec 2008 (as UMYLENDEX) Revised: 1 Oct 2021 (clarified pregnancy test) Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Pomalidomide is a third generation immunomodulatory (IMiDs) agent, which is a more potent version of . A phase II study of pomalidomide, daily low dose oral cyclophosphamide, and dexamethasone in relapsed/refractory multiple myeloma. A treatment-free week from day 21. All patients received pre‐infusion medication on daratumumab dosing days (≤3 h before dosing) comprising oral dexamethasone 40 mg (20 mg IV on Days 1, 2, 8, 15 and 22 of Cycle 1; 12 mg during maintenance cycles), acetaminophen 650-1000 mg IV or oral, diphenhydramine 25-50 mg IV or oral (or equivalent), and an optional leukotriene inhibitor (montelukast 10 mg oral or equivalent). Iberdomide plus low-dose cyclophosphamide and dexamethasone Available data indicates that the Cereblon E3 ligase modifying drug (CELMoD) iberdomide (CC220) is pharmacologically distinct from lenalidomide and pomalidomide with a higher potency against Cereblon, leading to differentiated antitumor and immunostimulating effects. Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) Versus Pomalidomide-Dexamethasone (PD) in Relapse or Refractory Myeloma Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have survival of less than 1 year. Patients underwent a 28-day treatment cycle; pomalidomide (4 mg/day on days 1-21, orally) plus dexamethasone (40 mg/day on days 1, 8, 15, and 22, orally). MM.1 Bendamustine, Thalidomide and Dexamethasone (BTD) MM.2 Bendamustine, Bortezomib and Dexamethasone (BVD) MM.3 Bone Protection in Myeloma MM.4 Bortezomib (Velcade) 21 day MM.5 Bortezomib (Velcade) 35 day MM.6 Bortezomib (Velcade), Lenalidomide and Dexamethasone (VRD) MM.7 Bortezomib (Velcade), Thalidomide and Dexamethasone (VTD . Belantamab is an antibody drug conjugate. The protocol required a bone marrow Median progression-free survival with elotuzumab plus pomalidomide and dexamethasone was 10.3 months and the overall response rate amounted to 53%, which alone demonstrates the superiority of this treatment over pomalidomide and dexamethasone (4.7 months in the group with pomalidomide plus dexamethasone, HR 0.54 (95% CI 0.34-0.86); p = 0.0080) . Cyclophosphamide (400 mg/day flat dose) was administered orally on days 1, 8, and 15. 394 (10214):2096-2107. This study is being done to learn more about the drug, pomalidomide and to gather data on its safety and side effects when used in combination with commercially available cyclophosphamide and dexamethasone. 1. Lancet. Keywords: Cyclophosphamide; Extramedullary myeloma; Pomalidomide. Patients . In Spain in January 2015 in the context of the Spanish Myeloma Group we set up a clinical care guideline for the treatment of RRMM patients, candidates for pomalidomide therapy, with POMCIDEX. Pomalidomide, cyclophosphamide, and prednisone for relapsed/refractory multiple myeloma: a multicenter phase 1/2 open-label study. Lancet Oncol. The main target is something called BCMA, which stands for B-cell maturation antigen. 54. -Cyclophosphamide -dexamethasone 5 -VRD -RD -RTX to spine -SCH on clinical trial -VRP -VRD -CRD . Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) Versus Pomalidomide-Dexamethasone (PD) in Relapse or Refractory Myeloma The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Baz RC, Martin 3rd TG, Lin H-Y, et al.

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