It's a study that looks at randomizing patients with newly diagnosed myeloma to RVd [lenalidomide, bortezomib, dexamethasone], which is the default standard of care, vs daratumumab with RVd [lenalidomide, bortezomib, dexamethasone]. Eligibility Criteria Locations & Contacts However, recent studies showed a deeper response and superior progression-free survival with quadruplet regimen, daratumumab-VRd, when compared to VRd. Lancet Oncol 2010; 11:29-37. January 14, 2022. The addition of daratumumab (D) to RVd (D-RVd) in transplant-eligible NDMM patients was evaluated. During a live virtual event, Saad Zafar Usmani, MD, discussed the findings of the CASSIOPEIA and GRIFFIN studies of daratumumab and lenalidomide in patients with newly diagnosed multiple myeloma. We sought to determine whether the addition of daratumumab would significantly reduce the risk of disease progression or death in this population. Those were the 2 choices. Patients receiving second- or third-line multiple myeloma treatment who had at least one dose of KRd (carfilzomib-lenalidomide-dexamethasone), Kd (carfilzomib-dexamethasone), DRd (daratumumab-lenalidomide-dexamethasone), DVd (daratumumab-bortezomib-dexamethasone), or lenalidomide as part of a combination therapy (other than the . Andrzej Jakubowiak, MD, PhD, professor of Medicine, University of Chicago Medicine, discusses safety results for daratumumab (Darzalex) combined with carfilz. The study results were published in the journal Future Oncology. During a live virtual event, Saad Zafar Usmani, MD, discussed the findings of the CASSIOPEIA and GRIFFIN studies of daratumumab and lenalidomide in patients with newly diagnosed multiple myeloma. Days 1-14: Lenalidomide 25mg orally once daily. This study was very important because on this particular trial, close to 50% of patients were over the age of 75 years old. Subsequently, daratumumab in combination with standard of care regimen showed clinical benefit in two different phase III trials involving patients with relapsed or refractory myeloma. The addition of daratumumab to lenalidomide and dexamethasone significantly lengthened progression-free survival among patients with relapsed or refractory multiple myeloma. METHODS : In this phase 3 trial, we randomly assigned 569 patients with multiple myeloma who had received one or more previous lines of therapy to receive lenalidomide and dexamethasone either alone (control group . Median progression-free survival was 12.5 months in both groups. Updated efficacy and safety after >3 years of follow-up are presented. Carfilzomib, lenalidomide and dexamethasone therapy is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. This Treatment Guide contains information about dexamethasone, a drug used in the treatment of myeloma. Targeted Oncology Staff. This phase II, multicenter, open-label study is studying daratumumab in combination with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma who have received at least one prior therapy and who have had previous treatment with both lenalidomide and a proteasome inhibitor. In pts with PI and IMiD refractory MM, weekly SDd demonstrated . Dvd- Daratumumab (DARZALEX®) with Bortezomib & Dexamethasone Multiple Myeloma Protocol V1.0. Rajkumar SV, Jacobus S, Callander NS, et al. Repeat cycle every 3 weeks for 3 . The clinical evidence came from ASPIRE, an open-label, randomised multicentre trial of carfilzomib plus lenalidomide and dexamethasone . Relapsed and relapsed/refractory multiple myeloma requiring systemic therapy; Failed at least one prior treatment for multiple myeloma (must have received lenalidomide) To be enrolled as second line therapy: Must be refractory to lenalidomide (progression on therapy or within 60 days of lenalidomide dosing) Siegel DS, Schiller GJ, Samaras C, Sebag M, Berdeja JG, Ganguly S, et al. Most people went to transplant and then maintenance after treatment for 2 years. Comparators . Received: 6 July 2021 Abstract: Daratumumab, a CD38-targeting monoclonal antibody, has significantly improved survival Accepted: 5 August 2021 rates in multiple myeloma (MM), yet patients who progress on Daratumumab have dismal clinical Published: 10 August 2021 outcomes with an overall median of less than 10 months. Daratumumab (DARA) Plus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Patients with Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM): Updated Analysis of Griffin after 12 Months of Maintenance Therapy Repeat cycle every 3 weeks for 3 . He then pointed to a 2021 study by C. Ola Landgren, MD, PhD, and colleagues published in JAMA Oncology regarding daratumumab plus carfilzomib, lenalidomide, and dexamethasone (Dara-KRd), which led to high rates of minimal residual disease (MRD) and PFS among patients with multiple myeloma. In: ClinicalTrials.gov [Internet]. Received: 6 July 2021 Abstract: Daratumumab, a CD38-targeting monoclonal antibody, has significantly improved survival Accepted: 5 August 2021 rates in multiple myeloma (MM), yet patients who progress on Daratumumab have dismal clinical Published: 10 August 2021 outcomes with an overall median of less than 10 months. Conclusions: Based on tolerability and efficacy, the RP2D of SDd is selinexor 100 mg, daratumumab 16 mg/kg and dexamethasone 40 mg, administered QW. The addition of daratumumab to lenalidomide and dexamethasone significantly lengthened progression-free survival among patients with relapsed or refractory multiple myeloma. Subsequently, daratumumab in combination with standard of care regimen showed clinical benefit in two different phase III trials involving patients with relapsed or refractory myeloma. DTPACE Myeloma Protocol V1.1. In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Daratumumab in addition to bortezomib, lenalidomide and dexamethasone is in clinical development for newly diagnosed multiple myeloma (MM). It is within the same class as the adrenal corticosteroids, such as prednisone, prednisolone, and methylprednisolone. Patients with relapsed/refractory multiple myeloma (RRMM) for whom the benefits of lenalidomide have been exhausted in early treatment lines need effective therapies. Ixazomib, Lenalidomide & Dexamethasone Multiple Myeloma Protocol V1.0. The addition of daratumumab to the standard of care regimen, including bortezomib and dexamethasone (CASTOR trial), or lenalidomide and dexamethasone (POLLUX . The FDA has approved daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy, based on findings from the phase III POLLUX and CASTOR studies. 2000-[cited 2016 Nov 11]. On November 30, 2021, it was announced that the U.S. Food and Drug Administration (FDA) approved the use of subcutaneous daratumumab (daratumumab + hyaluronidase-fihj) in combination with carfilzomib and dexamethasone (Dara-Kd) for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM) with ≤3 prior lines of therapy. Dexamethasone Treatment Guide. He then pointed to a 2021 study by C. Ola Landgren, MD, PhD, and colleagues published in JAMA Oncology regarding daratumumab plus carfilzomib, lenalidomide, and dexamethasone (Dara-KRd), which led to high rates of minimal residual disease (MRD) and PFS among patients with multiple myeloma. Pomalyst plus dexamethasone (Pd) is indicated for patients with multiple myeloma who have received at least two prior therapies including both Revlimid® (lenalidomide) and a proteasome inhibitor such as Velcade® (bortezomib), Kyprolis® (carfilzomib), or Ninlaro® (ixazomib), and have demonstrated disease progression on or within 60 days of . A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma. Patients receiving second- or third-line multiple myeloma treatment who had at least one dose of KRd (carfilzomib-lenalidomide-dexamethasone), Kd (carfilzomib-dexamethasone), DRd (daratumumab-lenalidomide-dexamethasone), DVd (daratumumab-bortezomib-dexamethasone), or lenalidomide as part of a combination therapy (other than the . 3 Dexamethasone is a steroid, which is usually combined with other drugs to enhance their effects when treating multiple myeloma. Peter M. Voorhees, MD, of the Levine Cancer Institute, Atrium Health in Charlotte, NC, discusses outcomes from the phase II GRIFFIN, presented at the ASH Ann. Laubach JP, Kaufman JL, Sborov DW, et al. multiple myeloma would welcome a new second-line treatment that gives longer periods of remission and improves survival. On August 20, 2020, the Food and Drug Administration approved carfilzomib (KYPROLIS, Onyx Pharmaceuticals, Inc . Introduction: Daratumumab (DARA) is a human, CD38-targeted, IgG1κ monoclonal antibody approved as monotherapy in heavily pretreated relapsed/refractory multiple myeloma (RRMM) and in combination with standard-of-care regimens for transplant-ineligible NDMM and RRMM. Daratumumab was . The study results were published in the journal Future Oncology. A recent study found that the use of daratumumab in treatment of multiple myeloma (MM) exceeds dosing recommended by the US Food and Drug Administration (FDA), leading to an extra cost per year for MM treatment estimated to be greater than $30,000. Days 1,8,15: Dexamethasone 40mg orally once daily. Pomalidomide + low-dose dexamethasone + daratumumab in relapsed and/or refractory multiple myeloma after lenalidomide . 00598a. Lenalidomide and dexamethasone (Rd) treatment is common for patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem-cell transplantation. Giving daratumumab, bortezomib, lenalidomide and dexamethasone may treat smoldering multiple myeloma and prevent progression to active or symptomatic multiple myeloma. Isatuximab with Pomalidomide and Dexamethasone Multiple Myeloma Protocol V1.0. There were two components of the study that we'll . Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT) is standard frontline therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). MM is a rare, incurable cancer of the plasma cells (a type of white blood cells) in the bone marrow (the spongy tissue at the centre of some bones) where large amounts of abnormal plasma cells are produced and interfere with the production of red and white . In this ongoing phase 1b trial, transplant-ineligible Japanese patients with NDMM received daratumumab (16 mg/kg . The increasing adoption of lenalidomide-based therapy for frontline treatment of multiple myeloma has resulted in a need for effective regimens for lenalidomide-refractory patients … Blood . Renal failure is a serious complication associated with multiple myeloma that can occur in up to 50% of cases at diagnosis.1 Although the introduction of novel anti-myeloma agents has improved outcomes, severe renal impairment is still associated with an early risk of death in patients with multiple myeloma.2,3 Renal injury occurs in multiple myeloma secondary to the direct toxic effect of . Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT) is standard frontline therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). A recent study found that the use of daratumumab in treatment of multiple myeloma (MM) exceeds dosing recommended by the US Food and Drug Administration (FDA), leading to an extra cost per year for MM treatment estimated to be greater than $30,000. DARZALEX (daratumumab) injection, for intravenous use . January 14, 2022. Carfilzomib (27mg/m2 twice weekly), Lenalidomide and Dexamethasone (KRd) Therapy - 28 day. Daratumumab (DARA) plus lenalidomide, bortezomib, and dexamethasone (RVd) in patients (pts) with transplant-eligible newly diagnosed multiple myeloma . Daratumumab is currently indicated as a single agent for patients with myeloma who have previously received 3 or more lines of therapy; in combination with lenalidomide (Revlimid) and . The FDA has granted approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro®, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. DARIA is an open, single arm, multicenter, phase 2 study of daratumumab in combination with ixazomib and dexamethasone in patients with relapsed multiple myeloma, who have received one prior line of therapy that consisted of a lenalidomide-based regimen. These steroids play an important role in treatment of multiple myeloma. (Funded … Daratumumab plus Rd (D-Rd) is effective and well tolerated for treating relapsed or refractory multiple myeloma. DARZALEX ® was studied in combination with Revlimid ® and dexamethasone (Rd) vs Rd alone in 569 patients who had received at least one prior medicine to treat their multiple myeloma.. Those with newly diagnosed disease were treated with 1800 mg of subcutaneous daratumumab in combination with either bortezomib (Velcade), lenalidomide (Revlimid) and dexamethasone (D-VRd) or . SparkCures ID. The daratumumab, lenalidomide, and dexamethasone triplet is a new frontline option for patients with multiple myeloma who are not candidates for transplant, but how practice-changing are the data? 1,2 In the POLLUX trial, adding daratumumab to lenalidomide and dexamethasone reduced the risk of . treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who . 2,6-8 The arrival of next-generation PIs brought additional PI-IMiD-based triplets to the clinic, including carfilzomib-lenalidomide-dexamethasone (KRd). Triplet regimen has been demonstrated to be more effective as compared to doublets, with VRd being the preferred induction regimen in newly diagnosed multiple myeloma (NDMM) based on . Lenalidomide & Dexamethasone Multiple Myeloma Protocol V1.1 Days 1-2,4-5,8-9,11-12: Dexamethasone 20mg orally once daily OR. The combination of lenalidomide-bortezomib-dexamethasone (RVd) is one of the more commonly used first-line induction regimens and has shown consistently high activity across studies. The main goal of the study was to measure the length of time patients lived without their multiple myeloma getting worse or passing . Bahlis:The MAIA trial was a randomized phase III trial of daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone in transplant-ineligible multiple myeloma. FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma. We searched PubMed for relevant trials published between Sept 1, 2011, and Dec 1, 2020, using the terms "multiple myeloma", "carfilzomib", "daratumumab", "relapsed", "refractory", "bortezomib", AND "lenalidomide", to provide an overview of treatment of relapsed or refractory multiple myeloma to compare the study . Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. The triplet regimen-bortezomib, lenalidomide, and dexamethasone, VRd, is the preferred induction regimen in newly diagnosed Multiple Myeloma (MM) due to its favorable impact on overall survival. Bethesda (MD): National Library of Medicine (US). 2019 Aug 1;134(5):421-431. doi: 10.1182/blood.2019000722. In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in. This publication is part of our Treatment Guide series, a collection of publications covering different drugs used in the treatment of myeloma. The addition of daratumumab to the standard of care regimen, including bortezomib and dexamethasone (CASTOR trial), or lenalidomide and dexamethasone (POLLUX . They have both anti-inflammatory and anti-myeloma effects. They are designed to be mixed-and-matched to correspond to your . Dexamethasone is one of the most frequently used medications in the treatment of multiple myeloma. n engl j med 380;22 nejm.orgMay 30, 2019 2105 Daratumumab, Lenalidomide, and Dexamethasone for Myeloma M ultiple myeloma is a hematologic cancer in which clonal plasma-cell pro - [PMC free article] [Google Scholar] Daratumumab (DARA) plus lenalidomide, bortezomib, and dexamethasone (RVd) in patients (pts) with transplant-eligible newly diagnosed multiple myeloma . Regimen. Pa … December 2021 Brea Lipe, MDClinical director of Wilmot Cancer Institute's multiple myeloma program and associate professor of hematology/oncology at the University of Rochester Medical Center Peter Voorhees, MDDirector, Outreach for Hematologic Malignancies, Plasma Cells Disorder Program, Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute The ORR was 73% (11 VGPR, 11 PR) for 30 daratumumab-naïve pts. Days 1-2,4-5,8-9,11-12: Dexamethasone 20mg orally once daily OR. "In a phase 1b study, intravenous daratumumab . BACKGROUND : Daratumumab showed promising efficacy alone and with lenalidomide and dexamethasone in a phase 1-2 study involving patients with relapsed or refractory multiple myeloma. December 2021 Brea Lipe, MDClinical director of Wilmot Cancer Institute's multiple myeloma program and associate professor of hematology/oncology at the University of Rochester Medical Center Peter Voorhees, MDDirector, Outreach for Hematologic Malignancies, Plasma Cells Disorder Program, Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute Part 2: Daratumumab Shows Greater PFS Benefit Early On in Multiple Myeloma. Most people went to transplant and then maintenance after treatment for 2 years. DARZALEX ® is given as an intravenous (IV) infusion after dilution at 16 mg/kg of actual body weight Lenalidomide is given orally on Days 1-21 of each cycle* Dexamethasone is given orally or IV once a week † In newly diagnosed, transplant-ineligible multiple myeloma: Background: Lenalidomide plus dexamethasone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. In cohort A of the phase 2 MM-014 trial, we examined the safety and efficacy of pomalidomide plus low-dose dexamethasone immediately after lenalidomide-based treatment failure in . DARZALEX ® in combination with Revlimid ® (lenalidomide) + dexmethasone. Those were the 2 choices. Days 1,8,15: Dexamethasone 40mg orally once daily. Dr. Voorhees: GRIFFIN was a clinical trial, a phase II clinical trial where we assessed the efficacy and safety of the addition of daratumumab into the lenalidomide, bortezomib, and dexamethasone, or RVd, backbone for patients with newly diagnosed multiple myeloma who were transplant-eligible. It's a study that looks at randomizing patients with newly diagnosed myeloma to RVd [lenalidomide, bortezomib, dexamethasone], which is the default standard of care, vs daratumumab with RVd [lenalidomide, bortezomib, dexamethasone]. Lenalidomide and dexamethasone is the only relevant comparator . 3.2 . Targeted Oncology Staff. Daratumumab plus Rd (D-Rd) is effective and well tolerated for treating relapsed or refractory multiple myeloma. 9 RVd and KRd were the first regimens with 100% response . Other options would include regimens that contain daratumumab (DPd, DRd, and DVd), bendamustine (eg, bendamustine, lenalidomide, and dexamethasone), 98 or an anthracycline-containing regimen such as bortezomib, doxorubicin, and dexamethasone 172; lenalidomide, doxorubicin, and dexamethasone 173; or bortezomib, pegylated liposomal doxorubicin . 3 Laubach JP, Kaufman JL, Sborov DW, et al. The active substance in Darzalex, daratumumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the protein CD38, which is found in high amounts on abnormal white blood cells in multiple myeloma and AL amyloidosis. Days 1-14: Lenalidomide 25mg orally once daily. Elotuzumab (Empliciti) is a humanized IgG1 monoclonal antibody targeting SLAMF7 indicated in combination with lenalidomide and dexamethasone for multiple myeloma in patients who have received 1-3 prior therapies; the dose is 10 mg/kg IV weekly for the first two 28-day cycles, and then 10 mg/kg IV q2wk (on days 1 and 15) Daratumumab was associated with infusion-related reactions and a higher rate of neutropenia than the control therapy. On July 9, 2021, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult . Lenalidomide and dexamethasone (Rd) treatment is common for patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem-cell transplantation. Part 2: Daratumumab Shows Greater PFS Benefit Early On in Multiple Myeloma. By attaching to CD38 on these cells, daratumumab activates the immune system to kill the abnormal white blood cells. On July 9, 2021, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult .

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