Hematologic Malignancies—Plasma Cell Dyscrasia

 
Angela Dispenzieri, Amrita Y. Krishnan, Bonnie Arendt,et al.
The study authors conclude that Mass-Fix is a powerful means to track monoclonal proteins. It provides a convenient and non-invasive means of predicting myeloma outcomes. Clinical trial information: NCT01109004
 
 
Noemi Puig, Bruno Paiva, Teresa Contreras, et al.
The study authors demonstrate that the results of minimal residual disease (MRD) assessed by Next Generation Flow (NGF) in bone marrow (BM) and by Mass Spectrometry (MS) in peripheral blood show a significant concordance and are associated with a similar prognostic value analyzed in terms of progression-free survival. Given its high negative predictive values, MRD in peripheral blood by MS provides a gateway for BM aspiration/biopsy and MRD assessment by NGF.
 
 
Benjamin Avi Derman, Jeffrey A. Zonder, Ankit J. Kansagra,et al.
The study authors conclude that the triple combination demonstrates tolerability consistent with known toxicities of these agents and met the primary endpoint of sCR and/or MRD(-) of >50% after 8 cycles. Clinical trial information: NCT02969837
 
 
Martin F. Kaiser, Nuria Porta, Bhupinder Sharma, et al.
The study authors conclude that whole-body MRI increases detection of focal and diffuse disease compared with Fluorodeoxyglucose PET/CT, including improved detection of focal lesions meeting criteria for active disease as per International Myeloma Working Group diagnostic criteria. These results are proposing it as a gold standard for tumor imaging in MM. Clinical trial information: NCT02403102
 
 
Mounzer E. Agha, Adam D. Cohen, Deepu Madduri, et al.
The study authors conclude that a single infusion ciltacabtagene autoleucel at the recommended phase 2 dose led to early and deep responses with a manageable safety profile in patients with multiple myeloma who had 1–3 prior lines of therapy. Updated efficacy and safety findings will inform the suitability of outpatient treatment in this and other cohorts of CARTITUDE-2 as well as the CARTITUDE-4 study. Clinical trial information: NCT04133636
 
 
Hua Jiang, Baoxia Dong, Li Gao, et al.
The study authors conclude that BCMA-CD19 dual FasT CAR-T GC012F showed early, deep and durable responses. They observed a high ORR (94.7% - VGPR and better) including a high MRD- sCR rate (DL3=100%, n=9) in high risk RRMM patients including those refractory to anti-CD38, PI and IMIDs with a favorable safety profile consistent with previous findings. They conclude, that BCMA-CD19 dual FasT CAR-T GC012F may present a new treatment approach for patients with RRMM including those with high-risk features refractory to standard of care. Clinical trial information: NCT04236011; NCT04182581
 
 
Matthew J. Frigault, Elizabeth O'Donnell, Noopur S. Raje, et al.
The study authors show encouraging early efficacy results, with 9/9 (100%) ORR and manageable toxicities, 8/9 responses are ongoing and responses continue to deepen. They conclude. that these data are encouraging in high-risk subjects with penta-refractory myeloma. Clinical trial information: NCT04155749
 
 
Larry D. Anderson, Jr, Nikhil C. Munshi, Nina Shah, et al.
The study authors conclude that the updated results from the KarMMa trial continue to demonstrate deep, durable responses with Idecabtagene vicleucel in heavily pretreated pts with RRMM. Efficacy and safety reflect prior reports: Patients previously exposed to immunomodulatory agents, proteasome inhibitors, and CD38 antibodies had poor outcomes with subsequent treatments. However, Idecabtagene vicleucel, a BCMA-directed CAR T cell therapy, showed frequent, deep, and durable responses in heavily pretreated pts with RRMM in the pivotal KarMMa trial. The updated results now support a favorable clinical benefit-risk profile for Idecabtagene vicleucel across the target dose range. Clinical trial information: NCT03361748
 
 
Paul G. Richardson, Aurore Perrot, Jesús F. San-Miguel, et al.
Isatuximab (Isa) is a monoclonal antibody that binds to a specific epitope on the CD38 receptor. The study authors conclude that this drug combined with pomalidomide and low-dose dexamethasone (Pd) demonstrates a significant improvement in time to next treatment and time from randomization to disease progression on first subsequent therapy or death compared with Pd alone. A strong trend in overall survival benefit was also seen in the Isa-Pd arm, with approximately 7 months improvement in median overall survival. The overall safety profile differed not from prior analyses. Clinical trial information: NCT02990338
 
 
Darrell White, Christine Chen, Muhamed Baljevic, et al.
The study authors conclude that selinexor, once weekly, can be safely combined with pomalidomide and low-dose dexamethasone in patients with heavily pretreated multiple myeloma. The all-oral triple combination is highly active with an ORR of 65% at the recommended Phase 2 dose (compared to expected ORR ≤30% for Pd). The combination produces durable responses with a median progression-free survival of 12.2 months overall. A phase 3 study with an all-oral combination of XPd vs Pd in patients who have been previously treated with LEN, a PI, and an anti-CD38 mAb is planned. Clinical trial information: NCT02343042
 
 
Thierry Facon, Holger W. Auner, Maria Gavriatopoulou, et al.
The study authors conclude that in an older patient population with a poor prognosis, the triple combination with selinexor, bortezomib, and dexamethasone (XVd) was associated with a significant survival benefit, improved progression-free and overall survival with reduced peripheral neuropathy. This treatment requires relatively short and infrequent clinic visits. The authors conclude, that XVd may be a simple, effective regimen for patients 65 years or older. Clinical trial information: NCT03110562
 
 
Meletios A. Dimopoulos, Fredrik Schjesvold, Vadim Doronin, et al.
The study authors conclude that ixazomib-dexamethasone (Ixa-dex) prolonged progression-free survival versus pomalidomide-dexamethasone (pom-dex) in these heavily pretreated, PI-exposed and/or intolerant, R-refractory patients. However, the difference was not statistically significant. Ixa-dex was well tolerated, with lower G≥3 adverse event rates versus pom-dex. Clinical trial information: NCT03170882