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    WNMyeloma asked a questionMultiple Myeloma

    Revlimid class action lawsuit? Have you seen this one?

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    WNMyeloma posted an update

    'It’s still not curable, but you can have a good life'

    Claudia Trost is learning how to live with incurable bone cancer.

    Myeloma survivor Claudia Trost helped to organize the first Kingston Multiple Myeloma March at Macdonald Park on Sunday. (Meghan Balogh/The Whig-Standard) JPG, KI

    The Kingston resident was diagnosed with multiple myeloma two years ago, after more than a decade of close blood monitoring when blood tests in her native Germany came back abnormal in 2005.

    “That was the first time that I ever heard about this type of cancer, which is unfortunately not curable, but treatable,” she said.

    Multiple myeloma, also known as myeloma, is the second most common form of blood cancer. The disease affects the plasma cell in bone marrow, and, according to Myeloma Canada, eight Canadians are diagnosed with the incurable disease every day.

    Trost underwent chemotherapy and then had a successful stem cell transplant in October 2018. She is now on a maintenance drug that will help her maintain her remission, and she is already back at her job as a program administrator with the Internal Medicine Residency Program at Queen’s University.

    In April she attended the national Canadian Multiple Myeloma Conference.

    “I didn’t at the beginning want to get too involved or talk about my cancer, but I met so many great people there. They told their survival stories, and I was so touched by that,” she said.

    She decided to get involved, and became the point of contact in Kingston to bring Myeloma Canada’s national fundraising walk to the city.

    Kingston hosted its first Multiple Myeloma March on Sunday, and Trost was the local spokesperson for the event.

    “I saw how much Myeloma Canada is doing in research and how many new medications came on the market in the last two to five years to improve our living and quality of life, and extending our life,” she said. “That’s why we’re here all together, to just support this cause.”

    The walk had raised more than $8,300 as of Sunday morning, with a goal of $10,000. Fifty-seven participants preregistered to take part in the inaugural Kingston walk.

    Trost started a multiple myeloma support group in Kingston, which had its first meeting last week. She sees her diagnosis as an opportunity to connect with others who are living with the same condition that she is.

    “In the support group as well, I see patients in the hospital and can be kind of a mentor, to talk about my experience, going through a stem cell transplant, and just be there for them,” she said.

    Trost hopes that by telling her own survival story, she can help raise awareness about a type of cancer that affects many Canadians.

    “Lots of people have the same impression: what is multiple myeloma? They have never heard about this kind of blood cancer,” she said.

    “It’s still not curable, but you can have a good life. I feel pretty healthy. I want to continue my life, what I did before. I know that my life can change every day, but I just hope that after going into remission, that the remission period will be very long and I will have a long and good life.”

    Kingston was one of 27 other communities across Canada to host a march.

    For more information about multiple myeloma, go online to www.myeloma.ca.


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    WNMyeloma posted an update

    Darzalex Combo Increases Response Rates in Newly Diagnosed Multiple Myeloma Patients, Trial Shows

    Adding Darzalex (daratumumab) to a combination of Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone — called the VRd combo — increases the proportion of people with multiple myeloma who experience a decrease in tumor burden, a Phase 2 trial shows.

    The results occurred among newly diagnosed patients eligible to receive high-dose therapy and autologous stem cell transplant (ASCT).

    The findings were presented by Janssen Pharmaceuticals at the 17th International Myeloma Workshop (IMW) meeting, held recently in Boston, in an oral presentation titled “Daratumumab + Lenalidomide, Bortezomib & Dexamethasone Improves Depth of Response in Transplant-eligible Newly Diagnosed Multiple Myeloma: GRIFFIN.” (See page 546 of the abstract book.)

    “The GRIFFIN study is the second randomized study to investigate the benefit of daratumumab for patients with newly diagnosed multiple myeloma who are eligible for a transplant, and the first in combination with lenalidomide for this population,” Peter M. Voorhees, MD, GRIFFIN principal investigator at Levine Cancer Institute, said in a press release.

    The randomized, open-label, GRIFFIN Phase 2 trial (NCT02874742) sought to determine if the addition of Darzalex to the VRd combo would be able to increase the percentage of people responding to treatment, compared with VRd alone.

    The trial’s primary endpoint was to determine the percentage of patients achieving a a stringent complete response (sCR). Secondary endpoints included overall response rate (ORR), as well as the percentage of patients achieving a very good partial response (VGPR) or better, and a complete response or better.

    Complete responses refer to total cancer eradication, while partial responses reflect a significant decrease in disease burden, with no signs of cancer spreading. Stringent complete responses are stronger type of a complete response. A very good partial response is a stronger type of a partial response. The overall response rate measures the percentage of patients whose cancer decreased by a given amount within the study’s time-frame.

    Key findings from GRIFFIN, presented at the IMW meeting, showed that:

    After completing six cycles of treatment, and receiving a stem cell transplant, a higher percentage of patients treated with Darzalex (42%) achieved a sCR compared with those treated with VRd alone (32%).
    Darzalex increased the percentage of patients who achieved a VGPR or better (91% versus 73%), a complete response or better (52% versus 42%), and an overall response (99% versus 92%), compared with the VRd combo alone.
    The Darzalex combination also increased the percentage of patients achieving a state of minimal residual disease (MRD) negativity — less than one malignant cancer cell found among 10,000 white blood cells — by more than two times compared with the VRd combo. Those results were 59% versus 24%.
    The most common severe (grade 3) and life-threatening (grade 4) treatment-emergent adverse events in those treated with Darzalex were low levels of blood cells. These included neutrophils (32%), lymphocytes (23%), platelets (16%), and leukocytes (15%);
    Mild (grade 1) and moderate (grade 2) infections were more frequent in people treated with Darzalex. However, the incidence of severe and life-threatening infections were similar in patients from both treatment groups.
    “This primary analysis of the GRIFFIN study builds on the safety and efficacy data in the initial group of 16 patients presented at the 2018 American Society of Hematology Annual Meeting,” said Andree Amelsberg, MD, MBA, vice president of oncology medical affairs at Janssen Biotech. “It provides further support for evaluation of Darzalex in the transplant-eligible patient population, which is important as we continue our work to discover new therapeutic approaches to improve outcomes for patients.”

    Janssen also presented new data at the IMW meeting from its ongoing PLEIADES Phase 2 trial (NCT03412565). That oral presentation was titled “Subcutaneous (SC) Daratumumab (DARA) in Combination With Standard Multiple Myeloma (MM) Treatment Regimens: An Open-label, Multicenter Phase 2 Study (PLEIADES).” (See page 24 of the abstract book.)

    PLEIADES is comparing the effects of a new formulation of Darzalex, administered in newly diagnosed patients by an under-the-skin (subcutaneous) injection in combination with either Velcade, Revlimid and dexamethasone, or with Velcade, melphalan and prednisone. Those with relapsed or refractory multiple myeloma are given under-the-skin Darzalex injection in combination with Revlimid and dexamethasone.

    Another group has been added to the trial, testing subcutaneous Darzalex in combination with Kyprolis (carfilzomib) and dexamethasone. That study, which is expected to end in November 2021, is still recruiting adults at select sites worldwide. Enrollment information is available here.

    New data from PLEAIDES has shown that, when delivered by an under-the-skin injection in combination with standard-of-care medications, the clinical activity and safety profile of Darzalex is similar to that of its intravenous (into the vein) formulation.

    However, the new subcutaneous formulation of Darzalex significantly shortened the median duration of treatment administration in all patient groups from three hours (intravenous infusion) to approximately five minutes.

    The incidence of infusion-related reactions and injection-site reactions was similar in all participant groups (approximately 7.5%). More than half of those in all groups reported severe and life-threatening treatment-related adverse events. However, only 8% of patients in all groups were forced to discontinue treatment due to these adverse events.

    “We’re excited about the opportunity to progress the innovation represented by the Darzalex subcutaneous formulation, which can be administered over the course of minutes and has the potential to offer a reduction in infusion-related events as compared to the approved intravenous formulation,” said Craig Tendler, MD, vice president of clinical development and global medical affairs, oncology, at Janssen Research & Development.

    “Data from the PLEIADES study demonstrates that the DARZALEX subcutaneous formulation can also be safely administered in combination with standard backbone regimens used for treatment naïve and relapsed/refractory patients with multiple myeloma. It has been included in our recent submission of a Biologics License Application to the U.S. Food and Drug Administration seeking approval of a new Darzalex subcutaneous formulation for patients with multiple myeloma.”

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    WNMyeloma posted an update

    The combination of melflufen and dexamethasone showed antitumor activity in patients with relapsed or refractory multiple myeloma (RRMM), both in those with and those without extramedullary disease (EMD), according to data from the phase II HORIZON study presented at the 17th International Myeloma Workshop (IMW). Response rates with the combination were higher than those observed in prior studies of other agents in this patient populaiton.

    Outcomes for patients with RRMM who have EMD remain very poor despite recent advances in therapy, and EMD incidence appears to be increasing. Only daratumumab (Darzalex) has shown significant single-agent activity against EMD, with an overall response rate (ORR) of 17% (3 of 18) reported in daratumumab-naïve patients.

    Melflufen is a novel, lipophilic, peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells in vitro, inducing irreversible DNA damage and apoptosis. Melflufen is 50-fold more potent than melphalan in MM cells in vitro due to increased intracellular alkylator activity.

    When presenting at IMW, Paul G. Richardson, MD, of Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, described outcomes for patients with and without EMD in the HORIZON study, a single-arm, open label, multicenter phase II study investigating melflufen plus dexamethasone in patients with RRMM refractory to available therapies (NCT02963493).

    Patients with RRMM (n = 136) received ≥2 prior lines of therapy, were exposed to immunomodulatory drug (IMiD) and proteasome inhibitor (PI)–based therapy and had disease that was refractory to pomalidomide (Pomalyst) and/or daratumumab. Patients received melflufen 40 mg intravenously (IV) on day 1 of each 28-day cycle and dexamethasone 40 mg weekly (20 mg for patients age ≥75 years) until progressive disease or unacceptable toxicity. Dexamethasone was also given on days 8, 16, and 22. Patients were followed for progression-free survival (PFS) and overall survival (OS) for up to 24 months after the end of treatment.

    The primary endpoint of the trial is ORR [≥ partial response (PR)]. Secondary endpoints included PFS, duration of response (DOR), OS, clinical benefit rate (CBR), time to relapse, time to progression, and safety. EMD assessment at screening was required for patients with known or suspected soft tissue and/or bone-related extramedullary plasmacytomas.

    Interim results were presented at the meeting both for patients with (n = 44) and without (n = 86) EMD. There were no major differences between the 2 groups for most baseline characteristics, other than anti-CD38 exposure. EMD incidence was associated with anti-CD38 exposure (P = .01); EMD occurred in 40% of patients who were exposed to anti-CD38 and in 11% of patients not exposed to anti-CD38.

    EMD was assessed per investigator choice and included multiple imaging modalities (eg, PET/CT, MRI) and physical examination. Most patients with EMD had multiple lesions at baseline (29 of 44); 41% had only bone-related lesions, and 59% had soft-tissue lesions with or without additional bone-related lesions. Central nervous system (CNS) involvement occurred in 5 patients (11%).

    ORR was 27% for patients without EMD and 23% with EMD; CBR was 45% and 30%, respectively. In patients with EMD, those with soft tissue involvement (n = 26) had an ORR of 19%; those with bone-related EMD (n = 18) had an ORR of 28%. There was no response seen in patients with CNS and EMD.

    Median DOR for patients without EMD was 4.4 months (95% CI, 3.5-11.2). For patients with EMD, median DOR was 3.4 months (95% CI, 1.8-15.4).

    Median PFS was 2.9 months (95% CI, 2.0-4.0) for patients with EMD and 4.6 months (95% CI, 4.0-5.6) for patients without EMD.
    Median OS was 5.8 months (95% CI, 5.0-11.8) for patients with EMD and 11.6 months (95% CI, 10.0-17.6) for patients without EMD.

    Median OS was 18.5 months versus 5.1 months, respectively, in patients with EMD that did and did not respond to melflufen plus dexamethasone. In patients without EMD, on the other hand, median OS was 17.2 months versus 8.5 months, respectively, for those with disease that did respond versus disease that did not. Of the intent-to-treat (ITT) population, 54% of patients received subsequent therapy in line with previously published data with no significant difference observed between patients with or without EMD.

    Safety profiles for patients with and without EMD in the ITT population were similar and the treatment was generally well tolerated with manageable toxicity. Serious adverse events (AEs) were predominantly hematologic; the incidence of non-hematologic AEs, including infections, was low and there were no treatment-related deaths reported.

    HORIZON enrolled one of largest cohorts of patients with RRMM and EMD in a prospective trial; enrollment is nearly complete (n = 156), with final analysis pending. Melflufen plus dexamethasone demonstrates encouraging activity in this patient population.

    Richardson concluded that these results support continued investigation in ongoing and future clinical trials, including 4 ongoing phase II and III trials, of melflufen-based combination therapy for this population with an unmet medical need.

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    WNMyeloma shared a video

    One of our own, Jim Bond, shared his American Cancer Society video with us. He is a 25+ year survivor of Multiple Myeloma. Listen to his video and get inspired.