Medicine Matters Sharing successes, challenges and daily happenings in the Department of Medicine Nadia Hansel, MD, MPH, is the interim director of the Department of Medicine in th. Each spring, the taxman comes knocking on your door looking for your share. Google was awarded a patent today (Jan Bonds are no longer a plain-vanilla investment. Our results underline similarities and differences between isatuximab and other anti-CD38 monoclonal. Durie discusses the latest information on the new monoclonal antibody, isatuximab, and how it compares to daratumumab. On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult. Overall, isatuximab 20 mg/kg QW/Q2W had an acceptable safety and tolerability profile and showed promising antitumor activity in Japanese individuals with RRMM. They are designed to be mixed-and-matched to correspond to your treatment combination, helping you. Both isatuximab and daratumumab interfere with IATs but at different magnitudes, reflecting distinct binding to CD38 on RBCs. Isatuximab is usually given in combination with another cancer medicine ( carfilzomib or pomalidomide) and a steroid ( dexamethasone ). 7) At least one event leading to pomalidomide temporary discontinuation: 32 (10. There are two FDA‐approved anti‐CD38 monoclonal antibodies for treatment of multiple myeloma: isatuximab and daratumumab. 1 BRIDGEWATER, N, March 2, 2020 /PRNewswire/ -- The U Food and Drug Administration (FDA) has approved Sarclisa ® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex. Isatuximab 5/6. Sarclisa (isatuximab) is used for the treatment of multiple myeloma. The COLEC10 gene provides instruc. PFS was assessed by prior lines and refractory status. Isatuximab is usually given in combination with another cancer medicine ( carfilzomib or pomalidomide) and a steroid ( dexamethasone ). At least one AE leading to isatuximab temporary discontinuation: 24 (8. Isatuximab (Sarclisa) and daratumumab (Darzalex) were conjugated to the chelator p-isothiocyanatobenzoyl desferrioxamine (p-SCN-DFO, Macrocyclics, Inc. Aug 5, 2021 · Isatuximab (Sarclisa ®; isatuximab-irfc in the USA) is an anti-CD38 monoclonal antibody (mAb) approved for use in the treatment of adults with multiple myeloma (MM): in combination with pomalidomide and dexamethasone for those with relapsed and refractory MM (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a. The study had a total of 19 patients that were initially scheduled, but only 14 showed up and became subjects in the study. b.e.r.t. 3) At least one AE leading to pomalidomide dose reduction: 17 (5. Apr 2, 2024 · What is isatuximab? Isatuximab is used treat multiple myeloma in adults. These antibodies can work in different ways, such as by stimulating. Conclusions. Patient eligibility criteria Patient with newly diagnosed multiple myeloma and eligible. Introduction. 8 Isatuximab induces cell death via IgG Fc-dependent mechanisms including antibody‐dependent cellular cytotoxicity, complement. Introduction: Findings from a previously conducted matching-adjusted indirect comparison (MAIC) between isatuximab plus carfilzomib with dexamethasone (IsaKd) and daratumumab plus lenalidomide and dexamethasone (DRd) among relapsed and/or refractory multiple myeloma (RRMM) patients receiving one to three prior lines of therapy (LoT) demonstrated a significantly better progression-free survival. Isatuximab is an antibody (a type of targeted drug therapy) that attaches to a specific protein commonly found on the surface of myeloma cells. Your doctor or nurse will be happy to answer any questions you have about your treatment. Isatuximab is usually given in combination with another cancer medicine (carfilzomib or pomalidomide) and a steroid (dexamethasone). CD38 is a transmembrane glycoprotein with ectoenzymatic activity that is expressed in hematologic malignancies as well as other cell types and tissues. Both groups received the approved schedule of intravenous. Tumour Type: Myeloma. Sarclisa combination therapy is first to demonstrate superiority to standard of care lenalidomide, bortezomib and dexamethasone (RVd) in a Phase 3 trial. Isatuximab is the only anti-CD38 mAb that induces direct apoptosis in MM cell lines in the absence of cross-linking agents and independently of effector cells 2, 3. Isatuximab concentrations were determined using a validated enzyme-linked immunoadsorption assay with a lower limit of quantification of 0. MRD negativity is expected to be an indicator of. Pomalidomide and dexamethasone are designed to kill or slow the growth of mutliple myeloma. Though prices, which were announced. Isatuximab is a monoclonal antibody targeting the transmembrane receptor and ectoenzyme CD38, a protein highly expressed on hematological malignant cells, including those in multiple myeloma (MM). 1 The median OS was not yet reached with isatuximab-Kd and was 50. fratline The goal was to determine if IsaKRd could be a more. Isatuximab is an immunoglobulin G1 monoclonal antibody targeting a CD38 transmembrane glycoprotein on multiple myeloma cells, with a mechanism of action similar to that of the anti-CD38 antibody daratumumab. SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein. Kim, Kamlesh Bisht, Hongfang Wang, Helgi Van de Velde, Tomas Jelinek, Catia Simoes, Felipe Prosper, Jesús F. Whether the addition of the anti-CD38 monoclonal antibody isatuximab to the VRd regimen would reduce the risk of disease progression or death among patients ineligible to undergo. At least one AE leading to isatuximab temporary discontinuation: 24 (8. However, little is known about whether the use of one prior CD38 mAb will alter the efficacy of another in subsequent. An excess of sometimes severe infectious episodes, particularly respiratory tract infection (including. Approved Labeled Indication: in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. PARIS, March 31, 2021 /PRNewswire/ -- The U Food and Drug Administration (FDA) has approved Sarclisa ® (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the. 6 Based on the Phase 3 ICARIA‐MM study, Isa is approved in combination with pomalidomide (P) and dexamethasone (d) for the treatment of adult patients with relapsed/. Product name : Isatuximab Catalog No : 1461640-62-9 1. Isatuximab (Sarclisa ®; isatuximab-irfc in the USA) is an anti-CD38 monoclonal antibody (mAb) approved for use in the treatment of adults with multiple myeloma (MM): in combination with pomalidomide and dexamethasone for those with relapsed and refractory MM (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a. CD38 is a potential target for antibody-based therapeutics due to it being highly and uniformly expressed on the. Isatuximab induces direct cytotoxicity via caspase-dependent and lysosome-associated pathways in MM cells ( 31 ), and also inhibits the ADP ribosyl-cyclase ectoenzymatic activities of CD38 ( 14 ). Isatuximab is usually given in combination with another cancer medicine ( carfilzomib or pomalidomide) and a steroid ( dexamethasone ). Final overall survival analysis follow-up is ongoing. Methods This was an open-label single-arm phase 1/2 study investigating the safety, pharmacokinetics, and preliminary efficacy of isatuximab in patients awaiting kidney transplantation. california dmv registration status On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult. Aug 5, 2021 · Isatuximab (Sarclisa ®; isatuximab-irfc in the USA) is an anti-CD38 monoclonal antibody (mAb) approved for use in the treatment of adults with multiple myeloma (MM): in combination with pomalidomide and dexamethasone for those with relapsed and refractory MM (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a. Aug 5, 2021 · Isatuximab (Sarclisa ®; isatuximab-irfc in the USA) is an anti-CD38 monoclonal antibody (mAb) approved for use in the treatment of adults with multiple myeloma (MM): in combination with pomalidomide and dexamethasone for those with relapsed and refractory MM (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a. Part B of this phase 1b study (ClinicalTrials. [7] It entered in Phase II trials for multiple myeloma [8] and T-cell leukemia in 2015. This is demonstrated by the isatuximab control and 2 patient samples containing M-proteins with distinct migration compared to isatuximab (Fig Compared to standard. This review summarizes the mechanisms of action, pharmacokinetics, pharmacogenetics, efficacy, and clinical safety of isatuximab in MM and compares isatuximab with daratumumab, the first anti-CD38 antibody developed, in terms of mechanism and efficacy. Isatuximab (ISA), an anti-CD38 monoclonal antibody with multiple mechanisms of tumor killing, has shown efficacy and an acceptable tolerability profile in Phase 1/2 studies in patients with refractory or relapsed and refractory MM (RRMM) (Richter et al. We aimed to evaluate the addition of isatuximab to weekly carfilzomib (K), lenalidomide (R), and dexamethasone (d; Isa-KRd) in transplant-eligible patients with newly diagnosed multiple myeloma and stratified maintenance by cytogenetic risk. Due to a mechanism‐based drug‐disease interaction, patients secreting IgG M‐protein exhibited a twofold lower drug exposure compared with patients with non‐IgG MM. ISATUXIMAB (EYE sa TUX i mab) treats a type of bone marrow cancer (multiple myeloma). An exposure‐response (E‐R) analysis using data from patients with relapsed/refractory multiple myeloma (RRMM) enrolled in a phase Ib clinical study who received isatuximab at doses from 5 to 20 mg/kg weekly for 1 cycle (4 weeks) followed by every 2 weeks thereafter (qw/q2w) in combination. Sep 27, 2023 · Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRD) is a well-tolerated and very effective induction treatment for newly diagnosed high-risk multiple myeloma, resulting in deep remissions. Isatuximab is often administered after unsuccessful daratumumab treatment. Expert Advice On Improving Your Home Videos Lat. Aug 5, 2021 · Isatuximab (Sarclisa ®; isatuximab-irfc in the USA) is an anti-CD38 monoclonal antibody (mAb) approved for use in the treatment of adults with multiple myeloma (MM): in combination with pomalidomide and dexamethasone for those with relapsed and refractory MM (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a. Isatuximab (Sarclisa®) is a monoclonal antibody used for the treatment of MM.

The Glu233 residue has a highly flexible sidechain, as evident from the poor quality of electron density maps. Introduction: The presence of high-risk chromosomal abnormalities [t(4;14), del(17p), and t(14;16)] has been linked with inferior outcomes in patients with multiple myeloma (MM). Background: Isatuximab, an anti-CD38 antibody, has been widely used in treatments for patients with relapsed/refractory multiple myeloma (MM). 2022 Mar;36(3):885-8881038/s41375-021-01431-x Authors Lisa B Leypoldt 1. Isatuximab (Sarclisa ®; isatuximab-irfc in the USA) is an anti-CD38 monoclonal antibody (mAb) approved for use in the treatment of adults with multiple myeloma (MM): in combination with pomalidomide and dexamethasone for those with relapsed and refractory MM (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a. This multicenter trial included 270 patients who were randomized to either isatuximab-VRd or isatuximab, lenalidomide, and dexamethasone. This review summarizes the mechanisms of action, pharmacokinetics, pharmacogenetics, efficacy, and clinical safety of isatuximab in MM and compares isatuximab with daratumumab, the first anti-CD38 antibody developed, in terms of mechanism and efficacy. ac odyssey perk hashid Isatuximab and daratumumab are anti-CD38 monoclonal antibodies used to treat refractory multiple myeloma. Aug 5, 2021 · Isatuximab (Sarclisa ®; isatuximab-irfc in the USA) is an anti-CD38 monoclonal antibody (mAb) approved for use in the treatment of adults with multiple myeloma (MM): in combination with pomalidomide and dexamethasone for those with relapsed and refractory MM (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a. Isatuximab, an IgG1 monoclonal antibody, targets a specific epitope of human CD38, inducing myeloma-cell death by multiple mechanisms. Here are three of them. Pronunciation of Isatuximab with 1 audio pronunciations Record the pronunciation of this word in your own voice and play it to listen to how you have pronounced it. Our results underline similarities and differences between isatuximab and other anti-CD38 monoclonal. 15 Isatuximab binding to CD38 triggers a number of Fc-dependent mechanisms—antibody-dependent cellular. Isatuximab is an anti- CD38 mAb intended to treat relapsed or refractory multiple myeloma. monday night football live score Despite its high efficacy, not all patients achieve a lasting therapeutic response with isatuximab. Each DP vial contains either 100 mg/5 mL or 500 mg/25 mL of isatuximab at concentration of 20 mg/mL with pH of 6 Each mL of solution contains 20 mg isatuximab, 122 mg histidine Isatuximab is a CD38 monoclonal antibody approved for relapsed or refractory multiple myeloma. Apr 2, 2024 · What is isatuximab? Isatuximab is used treat multiple myeloma in adults. Isatuximab and daratumumab are anti-CD38 monoclonal antibodies used to treat refractory multiple myeloma. Isatuximab (10 mg/kg weekly for 4 weeks, then every other week) was administered as a fixed-volume infusion of 250. On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult. In this updated subgroup analysis of the randomized, Phase 3 IKEMA study (NCT03275285) in relapsed/refractory multiple myeloma (RRMM), we evaluated progression-free survival (PFS) and depth of response with the anti-CD38 antibody isatuximab plus carfilzomib-dexamethasone (Isa-Kd) versus Kd, in 1q21+ patients and related subgroups, at long-term. Women of childbearing potential treated with isatuximab should use effective contraception during treatment and for at least 5 months after cessation of treatment. sixflags com Sarclisa regimen reduced risk of disease progression or death by 45% compared to standard of care in patients who had relapsed after one to three prior therapies. A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab Blood Cancer J. Here, the authors review the published data regarding the development and clinical investigation of isatuximab, a CD38 monoclonal antibody, for treatment of patients with relapsed/refractory multiple myeloma. IMROZ and BENEFIT, randomized phase 3 trials presented at ASCO Annual Meeting, investigated the combination of isatuximab (Sarclisa, Sanofi) with bortezomib, lenalidomide and dexamethasone (VRd. Sep 27, 2023 · Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRD) is a well-tolerated and very effective induction treatment for newly diagnosed high-risk multiple myeloma, resulting in deep remissions. 5 days ago · Isatuximab, an IgG1 monoclonal antibody, targets a specific epitope of human CD38, inducing myeloma-cell death by multiple mechanisms. Overall, 73 patients received four 6-week induction cycles of. Investing money in stocks and bonds rather than stashing it in savings can help combat against inflation.

DALLAS, March 11, 2022 /PRNews. Limited real-world evidence (RWE) exists for patients treated with Isa-Pd/Isa-Kd. Forty-five patients received isatuximab (5 [n = 8], 10 [n = 31], or 20 [n = 6] mg/kg). Background: Bortezomib, lenalidomide, and dexamethasone (VRd) is a preferred first-line treatment option for patients with newly diagnosed multiple myeloma. See Important Safety & Prescribing Info. IMROZ: Isatuximab combined with standard-of-care bortezomib, lenalidomide, and dexamethasone significantly improves PFS and promotes deep response in patients with transplant-ineligible, newly diagnosed multiple myeloma (Abstract 7500). Purpose The GMMG-CONCEPT trial investigated isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in transplant-eligible (TE) and transplant-noneligible (TNE) patients with newly diagnosed multiple myeloma (NDMM) with exclusively high-risk disease for whom prospective trials are limited, aiming to induce minimal residual disease (MRD) negativity. 41 The same study also found that CD38 expression on Tregs is also upregulated by the IMiDs lenalidomide and pomalidomide. This review summarizes the mechanisms of action, pharmacokinetics, pharmacogenetics, efficacy, and clinical safety of isatuximab in MM and compares isatuximab with daratumumab, the first anti-CD38 antibody developed, in terms of mechanism and efficacy. Isatuximab is usually given in combination with another cancer medicine ( carfilzomib or pomalidomide) and a steroid ( dexamethasone ). Isatuximab is a monoclonal antibody targeting the transmembrane receptor and ectoenzyme CD38, a protein highly expressed on hematological malignant cells, including those in multiple myeloma (MM). Isatuximab PKs were characterized by a two‐compartment model with parallel time‐varying linear clearance (CL) and nonlinear elimination. After that, responders received cemiplimab 250mg and isatuximab 10mg/kg once every 3 weeks up to 24 months or until progression, death, or study withdrawal. The authors concluded that isatuximab plus VRd significantly increased MRD endpoints, including the 18-month negativity rate at 10 −5, the study primary endpoint, compared with isatuximab plus Rd. FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly reduced the risk of. On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult. Many clinical studies have demonstrated the efficacy and efficiency of. In patients with newly diagnosed, transplant-ineligible multiple myeloma, addition of weekly bortzomib to isatuximab, lenalidomide and dexamethasone leads to increased minimal residual disease. Daratumumab, isatuximab, elotuzumab, and belantamab mafodotin were found significantly associated with TLS than other drugs in the FAERS database (IC 025 > 0) in the primary analysis. " Donna Reece, MD, FRCPC Senior hematologist who cares for myeloma patients ncrease the chances of a negative crossmatch. The Committee wishes to draw the attention of prescribers to the need for specific vigilance with respect to the risk of immune deficiency induced by the long-term administration of SARCLISA (isatuximab), as it did for DARZALEX (daratumumab). Isatuximab is a monoclonal antibody that binds to a specific extracellular epitope of CD38, triggering mechanisms that result in the death of CD38-expressing tumour cells. It is given to adults who have received at least two previous treatments for their cancer, including lenalidomide and a proteasome inhibitor, and whose cancer has worsened since receiving the last treatment. Isatuximab is an anti-CD38 monoclonal antibody that can induce apoptosis in myeloma cells through a variety of mechanisms. doberman puppies for sale pennsylvania Objective We tried to identify biomarkers to predict the effectiveness of isatuximab by focusing on the host's immune status before treatment The randomized, phase 3 ICARIA-MM study investigated isatuximab (Isa) with pomalidomide and dexamethasone (Pd) versus Pd in patients with relapsed/refractory multiple myeloma and ≥2 prior lines. Prior to Isa-Pd regulatory approval, Isa was available in France under early access programs (EAPs). Subcutaneous (SC) delivery allows for a shorter duration of administration (within several minutes) compared with the currently approved IV route, optimizing convenience of administration and. Information for HCPs about SARCLISA (isatuximab-irfc), a therapy for relapsed or refractory multiple myeloma. Therefore, this retrospective cohort study assessed the clinical outcomes of 39 patients with multiple. Isatuximab overview. Isatuximab is a mAb that binds to a specific epitope on the human CD38 receptor and initiates a cascade of events, leading to depletion of CD38-expressing tumor cells via multiple different mechanisms. On the basis of the phase III ICARIA-MM study, isatuximab (Sarclisa) is approved in a number of countries in combination with pomalidomide and dexamethasone for the treatment of adult patients. Kim, Kamlesh Bisht, Hongfang Wang, Helgi Van de Velde, Tomas Jelinek, Catia Simoes, Felipe Prosper, Jesús F. Here, we report the final OS analysis. 5 ng/mL, whereas a validated liquid chromatography/tandem mass spectrometry method was used to measure LEN concentrations (lower limit of quantification: 5 ng/mL). It is administered to adults who have received at least two previous lines of therapy, including lenalidomide and a proteasome inhibitor, and whose myeloma has. 90%, are considered highly sensitized and underserved by the Kidney Allocation. ) The antibodies were prepared as a 2 mg/mL solution in PBS, and the solution pH was adjusted to 9 with 0 DFO-NCS was dissolved in dry DMSO at a concentration of 10 mg/mL, and a 4. Please see Important Safety Information throughout and accompanying full Prescribing Information. Advertisement A personal loan — an installment loan, usually unsecured, that you can use for anyth. uk millionaire maker code tonight It is administered to adults who have received at least two previous lines of therapy, including lenalidomide and a proteasome inhibitor, and whose myeloma has. 目前， Isatuximab 注射液已在美国、欧盟、亚太等全球多个国家和地区获批。同时，赛诺菲正在进行的 III 期临床试验，将继续评估 Isatuximab 注射液联合现行标准方案治疗多发性骨髓瘤。 Isatuximab 注射液用于治疗其他血液恶性肿瘤和实体瘤的研究也在进行中。 Isatuximab was given on days 1, 8, 15, and 22 in cycle 1, and then every 2 weeks thereafter. 5%) experienced an isatuximab infusion reaction, which was a low grade (G1) in all cases and did not lead to inpatient admission or treatment delays/discontinuations. This information from Lexicomp ® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider Sarclisa. It induces apoptosis of CD38 + cells through Fc-dependent and Fc-independent mechanisms , depletes B-lymphocyte precursors , and depletes NK cells through direct activation and crosslinking of CD38 and CD16 on NK cells. Isatuximab is a monoclonal antibody targeting the transmembrane receptor and ectoenzyme CD38, a protein highly expressed on hematological malignant cells, including those in multiple myeloma (MM). Isatuximab in combination with carfilzomib and dexamethasone (IsaKd) improves progression-free survival (PFS) relative to carfilzomib plus dexamethasone (Kd) among patients with multiple myeloma who have received 1 to 3 prior lines of therapy. Last updated: October 2022. CHICAGO — Isatuximab combined with a standard first-line treatment regimen significantly reduced the risk for disease progression and death in certain older individuals with multiple myeloma. The authors concluded the quadruplet combination of isatuximab (isa) plus KRd [carflizomib, revlimid, dexamethasone], performed significantly better than the triplet combination of KRd when looking for any myeloma cells at the 10 5 level (1 in 100,000) or 10 6 level (1 in 1,000,000). Phase III studies have shown a benefit of isatuximab added to standard backbone regimens, with the combination of isatuximab, pomalidomide, dexamethasone in the ICARIA study and isatuximab, carfilzomib. Multiple myeloma is rare, and Sarclisa was designated an 'orphan medicine' (a medicine used in rare diseases) on. Bortezomib was administered weekly and subcutaneously on days 1, 8, 15 at 1. Isatuximab, an IgG-kappa anti-CD38 mAb is effective as a single agent and is well tolerated in patients with RRMM 5,6. The primary efficacy endpoint was progression-free survival (PFS) and key secondary efficacy endpoints included overall. Isatuximab (Sarclisa ®; isatuximab-irfc in the USA) is an anti-CD38 monoclonal antibody (mAb) approved for use in the treatment of adults with multiple myeloma (MM): in combination with pomalidomide and dexamethasone for those with relapsed and refractory MM (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a. San-Miguel, Ana Alfonso, Juan Miguel Bergua Burgues, Rebeca Rodríguez-Veiga, Susana Vives, David Martínez-Cuadrón, Pau Montesinos, Bruno Paiva, Aintzane Zabaleta; Targeting. The Study. Isatuximab is a monoclonal antibody targeting the transmembrane receptor and ectoenzyme CD38, a protein highly expressed on hematological malignant cells, including those in multiple myeloma (MM). Isatuximab is a chimeric monoclonal antibody targeted against surface CD38 glycoproteins for the treatment of multiple myeloma in patients who have failed previous therapies. SARCLISA will be given to you by your healthcare provider by intravenous (IV) infusion into your vein. This subgroup analysis examined results from patients with RI, defined as estimated glomerular. 5 months in patients with RRMM. Patients received isatuximab either as monotherapy (20 mg/kg on days 1, 8, 15, and 22 [once weekly] of cycle 1 followed by 20 mg/kg on days 1 and 15 of subsequent cycles; Isa group) or in combination with dexamethasone (40 mg/d [20 mg/d in patients aged ≥75 years] once weekly; Isa-dex group). The phase III IKEMA study (clinicaltrials gov.