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Myeloma Highlights from ASH 2015 Conference

| Jack Aiello

This is my tenth year attending ASH (American Society of Hematology), where 25,000 attendees from all over the world (hematologists/oncologists, lab researchers, oncology nurses, scientists & 300 pharma companies) present the latest research results during both oral presentations (1000) as well as on posters (3000) that cover all blood cancers. This year there were nearly 800 abstracts (more than 100 clinical abstracts) on myeloma alone, many of which were selected for oral presentation. I’m grateful to the IMF and their pharma donors for sending me to ASH so that I can learn and then share my patient perspective with you.

Rather than attending talks on biology, I typically focus on the Clinical Trials, which I’m able to understand; in addition, they are definitely more relevant near-term to patients. Even at that, there are overlapping MM oral sessions as well as 4’ x 6’ posters without reprints. (It’s always possible that I have not included something of interest to you or made a typo because I can’t read my own writing. During sessions, detailed PowerPoint slides are presented quickly.) You might want to view the published abstracts at www.hematology.org and various press releases. Wherever possible, I’ve listed references in the following format {Day-Abstract#-Lead Investigator after the trial results. One example is this: {Sat-25-B. Durie}, and by clicking on the abstract number, the link will take you to the actual abstract.

The IMF has provided other ways to learn more about results from this conference. You can tune into the Best of ASH 2015: What Patients and Caregivers Need to Know on Thursday, January 7, 2016, at 4 PM PT / 7 PM ET. Listeners to the teleconference will also have a chance to participate. Dr. Durie will share take-aways from ASH 2015 and then open up the forum for a thirty-minute question and answer session with you. If you cannot catch the teleconference live, you can catch replays of all IMF ASH medical meetings HERE. You can also find individual interviews of doctors who were present at ASH 2015 HERE. Last, and definitely not least, you’ll also find some patient blogs (including mine), at the IMF at ASH 2015 site.

Presentations and posters of clinical trial results follow the same format: Background (including hypothesis), Study Objective, Design and Treatment schema, Patient Characteristics and Cohorts, Responses (include high-risk cytogenetics), Toxicity (hematological and non-hematological), Conclusion, and Next Step. Remember, the goal of phase I (typically a handful of patients) is to determine “Maximum-Tolerated Dose.” Phase I/II and II (typically 25 to 75 patients) continues to measure dosage escalation and safety while looking at responses; and finally, phase III (several hundred patients) compares response rates between new and current treatments.

Treatment schedules are defined for stages of Induction, and optionally Transplant, Consolidation, and Maintenance with specified Randomization along the way; dosage amounts and scheduling are provided for each drug along with optimum number of treatment cycles (typically 28 days). Risk stratification correlates various techniques such as cytogentics-FISH analysis (e.g. chromosome deletions and translocations), and gene-expression profiling (GEP).

HIGHLIGHTS (e.g. My Takeaways)

  1. The Ultra High Risk (plasma% > 60%, Free light chain ratio (FLC) > 100, >1 focal lesions) Smoldering multiple myeloma patients (SMM) have already been re-classified as MM patients, even without CRAB criteria (See the Glossary of Myeloma Acronyms for a better understanding of CRAB criteria and Free Light Chain Ratio.) Other SMM patients that have some indication of high-risk features (e.g. perhaps plasma% > 10% and one of FLC ratio > 8 or cytogenetics such as del17p) should investigate participation in a clinical trial such as E3A06 to determine the efficacy of early treatment.
  1. Three-drug VELCADE®/Revlimid®/dexamethasone (VRd) therapy for newly diagnosed patients has been shown to have longer progression free survival (PFS) and overall survival (OS) than two drugs and should be considered the standard of care. Mayo’s M-SMART (msmart.org) treatment protocol recommendation for newly diagnosed, standard- and intermediate-risk patients has been updated from Rd to VRd. However, it is still Kyprolis/Revlimid/dex [KRd] for high-risk.
  1. For relapsed patients, treatment isn’t as clear cut but with the recent approvals of Darzalex (Daratumumab), Ninlaro (Ixazomib), and Empliciti (Elotuzumab), patients have more options as they combine each of these with the baseline Rev-dex. How clinicians will use or “sequence” daratumumab/Revlimid®/dexamethasone, ixazomib/Revlimid®/dexamethasone, and elotuzumab/Revlimid®/dexamethasone will likely be better understood over the next one to two years. Because of this, it may be even more beneficial for patients to have a myeloma expert as part of their treatment team.
  1. Minimum Residual Disease (MRD)-testing is not ready for prime time, but it has good prognostic value for MM patients. MRD still needs to be consistently defined using Next-Generation Sequencing (NGS) or Next-Generation Flow (NGF). Trade-offs include NGS needs diagnostic sample and has higher cost while Flow needs “fresh” samples. And more trials need to integrate MRD-testing so that clinicians can eventually use MRD results to help guide future treatment plans. And probably, MRD-testing needs to be combined with PET-CT scans to get the complete picture.
  1. In the large French/US study comparing early versus late Stem Cell Transplantation (SCT), the French showed a progression free survival benefit, but not a three-year overall survival benefit (both arms about 83%). In my opinion, this may be because trial results are not yet mature. However, the French part of the study only uses one year of maintenance, whereas the US uses maintenance until progression. The US has yet to report data, so the question remains: Will maintenance make a difference to the outcome? We shall see.
  1. You’ll see reports below that look at survival outcomes such as Progression Free Survival (PFS) and Overall Survival (OS). However, with new treatments available, OS (i.e. death) become less meaningful for a particular drug. Perhaps the assessment of targeted biomarkers will become better measurements of drug efficacy.
  1. Regarding Early Treatment: “In most cancers (lung, breast), early diagnosis and treatment is a prerequisite to OS improvement. When we wait, clones have a chance to develop more aggressive subclones. But we must work to develop predictive biomarkers.” –Jesús F. San-Miguel, MD, PhD, Hospital Clinico Universitario, Universidad de Salamanca, Spain. However, “Should you over-treat 30% of high-risk smoldering multiple myeloma at the risk of under-treating 70%? What about toxicity? You need more evidence-based medicine.” Philippe Moreau, MD, University Hospital, France.
  1. Regarding Using Emerging Therapies up front: “Adding later does not add up.” Shaji Kumar, MD, Mayo Clinic-Rochester
  1. Flow cytometry testing, next generation flow (NGF) and next-generation sequencing (NGS), that is, measure myeloma inside the bone marrow, whereas PET-CT scans measure myeloma outside the bone marrow.—Alberto Orfao, MD, PhD, University of Salamanca, Spain
  1. We are still trying to determine the role of maintenance. There have been or are currently 242 clinical trials involving maintenance (including “consolidation and “continuous therapy”). Even vaccines (e.g. dendritic cells) are being tested as maintenance. —Thierry Facon, MD, Lille University Hospital, Lille, France.
  1. I attended an FDA presentation, during which each FDA doctors reviewed their criteria for approving Darzalex® (daratumumab), Ninlaro® (ixazomib), and Empliciti® (elotuzumab), respectively. These doctors cited the specific trial as well as primary and secondary endpoint results. Next, Drs. Vincent Rajkumar (Mayo Clinic) and Paul Richardson (Dana-Farber Cancer Institute) discussed using these new drugs in the frontline and relapsed therapy settings, respectively. Dr. Rajkumar began by saying, “Myeloma treatment is moving so fast, the Education Session I gave 2 days ago is already out of date.” To use these drugs in frontline therapy, they would be need to be “off-label,” and it’s better to use them within a clinical trial for newly diagnosed patients. Dr. Richardson explained that Revlimid®/dexamethasone is the “backbone,” and we can add VELCADE®, Kyprolis® (carfilzomib), Ninlaro® (ixazomib), Darzalex® (daratumumab), and Empliciti® (elotuzumab) (and Anti-CD38 antibody SAR in the future?). We’ll understand more about sequencing these combinations in the next one to two years.

SMOLDERING MM

  1. “If it’s smoldering, is there a fire?” Sagar Lonial, MD (Emory); and “Some patients with SMM really have monoclonal gammopathy of undetermined significance (MGUS) and others MM . . . we just don’t know which ones.” –S. Vincent Rajkumar, MD (Mayo Clinic)

FRONTLINE THERAPY FOR TRANSPLANT ELIGIBLE PATIENTS

  1. Phase III, n=525 newly diagnosed multiple myeloma patients (NMDD), VRd versus Rd. Overall Response Rate ORR (82% versus 72%), complete response (CR) (16% versus 8%) Progression Free Survival (43 versus 30 months) and Median Overall Survival (75 versus 64 months), all showed the benefits of triplet therapy over doublet. {Sat-25-B. Durie}
  1. Phase I and II, newly diagnosed multiple myeloma patients, n=48 including 30% high-risk multiple myeloma patients, Panobinostat (10mg) + Lenalidomide/Bortezomib/Dexamethasone ( RVd). Overall response rate after four cycles was 94% (CR/nCR 46% . . . compared with past trials RVd-only complete response is 10-20%) and 14 of 26 patients were MRD-negative before their stem cell transplantation. Adverse side effects (ASE) Grade 3 nausea 6% and peripheral neuropathy 4%. {Sun-187-J. Shah}
  1. Phase 3, n>2000 newly diagnosed multiple myeloma patients, comparing Kyprolis® (Carfilzomib), Cyclophosphamide, Lenalidomide, and Dexamethasone (KCRd) with Lenalidomide, cyclophosphamide, and dexamethasone (CRd) and Cyclophosphamide, thalidomide, and dexamethasone (CTd). It showed the four-drug regimen that added Kyprolis® (carfilzomib) resulted in greater than or equal to very good partial response (VGPR) (82% versus 62% versus 55%) and that KCRd had lower (!) hematological suppression than CRd (9% versus 16%). {Sun-189-C Pawlyn, UK}

FRONTLINE THERAPY FOR TRANSPLANT INELIGIBLE PATIENTS

  1. Phase II, n=70 newly diagnosed multiple myeloma patients, Ixazomib-Cytoxin-Dex (ICd) randomized to C = 300 or 400 mg all oral therapy. Plus Ninlaro® (ixazomib) maintenance. Early overall response rate results better in C=300 arm (78% versus 75%) and >=VGPR (28% versus 21%). Progression free survival at 9 months was 90%, but the data is not yet mature. {Sat-26-M. Dimopoulus}
  1. {FIRST subgroup analysis} n=142 High Risk [del 17p, t(4;14) or t14;16)] newly diagnosed multiple myeloma patients, randomized to 3 arms: Rd till progression versus Rd 18 cycles versus melphalan, prednisone, and thalidomide (MPT) 12 cycles. In non-high-risk multiple myeloma patients, median progression free survival was 31 months versus 21 months versus 25 months. With high-risk multiple myeloma patients, median progression free survival was 31 months 8 months versus 18 months versus 15 months. In non-high-risk multiple myeloma patients, three-year OS % was 77% versus 71% versus 65%, while the same length of OS in high-risk multiple myeloma was 41% versus 40% versus 47%. So while Rd till progression was the winner overall in the FIRST trial, it did not do so well comparably in high-risk multiple myeloma patients. {Mon-730-H. Avet-Loiseau}
  1. Phase II, n=40 “RVd-lite” study Revlimid® = 15mg, days 1-21; Vel = 1.3 mg/m2 once/week; dex = 40 mg/week for patients <75 years old and 20 mg/week otherwise. After four cycles, the overall response rate was 90% (including complete response of 25%), two-year progression free survival is 68%. {Mon poster-4217-E. O’Donnell}

TRANSPLANTS

  1. Phase III, n=700 70 newly diagnosed multiple myeloma patients, “Determination” RVd +/- Stem cell transplantation (SCT) + RVd consolidation + R maintenance. The French side of this study showed benefits in the SCT arm for ORR (88% versus 78%), CR (59% versus 49%), four-year PFS (47% versus 35%), and MRD (80% versus 65%). However, there was no OS difference (83%), which could be due to the short time frame as well as early crossover to the SCT arm. {Sun-391-M. Attal}
  1. Phase III, n=389 newly diagnosed multiple myeloma patients, SCT versus Cytoxin-Rd followed by Revlimid®/Prednisone (RP) versus Prednisone maintenance. SCT showed improvement in median PFS (43 versus 29 months) and four-year OS (86% versus 73%). Median PFS from the start of maintenance was 38 months for RP versus 29 months for R-only. However, three-year OS was similar (83% versus 88%). Of note, at the start of maintenance, MRD was 48% for the SCT arm versus 28% for lenalidomide, cyclophosphamide, and dexamethasone (CRd), even though complete response and very good partial response numbers were very close. {Sun-392-F. Gay, Italy}
  1. Phase III, n=174 (of 297 enrolled) prior SCT patients. Salvage SCT was defined as a second SCT after relapse > 18 months from before SCT. All patients were re-induced with PS-341/bortezomib, doxorubicin, and dexamethasone (PAD-combination therapy) and randomized to either second SCT versus a regimen of 12 weeks of Cytoxin with crossover. Overall response rate to re-induction was 79%. Four-year OS was 69% (with a second SCT) versus 61% (crossed over to second SCT) versus 50% (no second stem cell transplant). In conclusion, it is beneficial to have salvage SCT sooner. {Sun-394-G. Cook, UK}

TREATMENTS FOR RELAPSED/REFRACTORY (R/R) PATIENTS

  1. Combination of two phase II trials, n=148 patients, double-refractory to a proteasome inhibitor and immunomodulatory drugs (IMiDs) than Daratumumab alone (!). Dosage 16mg/kg. ORR= 31%; median PFS was 7.4 months; 1 year OS 69%. For patients who responded, the OS results were even better: OS for minimal response/stable disease patients= 17.5 months, and not reached for >=partial response. Ten to eighteen percent of patients experienced some hematological adverse side effects (ASEs). {Sat-29-S. Usmani}
  1. Phase II, n=32 relapsed/refractory multiple myeloma patients. Daratumumab (16mg/kg) + Rd. ORR 81% (compared with Rd ORR 61-66% for similar patients); 63% >= VGPR. Progression free survival at 12 months 91% (compared with Rd median PFS 11-15 months for similar patients) and PFS at 18 months 72%. Overall survival at 18 months 90%. Adverse side effects similar to Rd-alone other than some infusion reaction, usually only with the first infusion. {Mon-507-T. Plesner, Denmark} Note: Dr. Torben Plesner was the first doctor to treat a multiple myeloma patient with daratumumab in 2007.
  1. Phase Ib, n=98 relapsed/refractory multiple myeloma patients with at least two lines of prior therapy. Dara + pomalidomide and dexamethasone (Pom + d). Sixty-seven percent of patients were refractory with IMiDs and proteasome inhibitors, yet POM-naïve. ORR 71% (nearly same for double-refractory) including 9% complete response. Progression free survival at six months is 66%. Adverse side effects similar to Pom-d alone other than half of patients had Infusion Rate Reaction (IRR) during the first infusion but only 3% at second infusion. {Mon-508-A. Chari}
  1. Phase II, n=152 relapsed/refractory multiple myeloma patients, 50% prior VELCADE® treatment, one to three prior therapies. Empliciti (elotuzumab) (10 mg/kg) +/- VELCADE®/dexamethasone (EVd). Benefits in >= VGPR (36% versus 27%), median PFS (10 months versus 7 months) while ORR about the same (65% versus 63%). Grade 3/4 adverse events (AEs) higher in EVd (71%) than VELCADE®/dex (60%), most of this difference being infections (23% versus 15%). {Mon-510-A. Palumbo}
  1. {Eloquent-2} Phase III, n=646 relapsed/refractory multiple myeloma patients, Elotuzumab +/- Rd. Elo-Rd showed PFS benefit 4.5 months (19.4 versus 14.9) with very similar adverse events except infusion reaction in 10% patients (of which 63% were in the first infusion). {Sat-28-P. Richardson}
  1. {Endeavor subgroup analysis}Phase III, n=210 high-risk relapsed/refractory multiple myeloma patients, Kyprolis/dex (Kd) versus VELCADE/dex (Vd). PFS benefit ~3 mos (8.8 months versus 6 months); ORR 72% versus 58% (Complete Response 16% versus 4%). 1 to 2% (3% versus 1%) experience more cardiac issues in the Kd arm. {Sat-30-Wee-Joo Chng}
  1. {Endeavor subgroup analysis}Ph 3, n=465 relapsed/refractory multiple myeloma patients, Kd versus Vd outcomes for 1 and 2+ prior lines of therapy. Median PFS: 1 line 22 versus 10 mos; 2+ lines 15 versus 8 mos. ORR: 1 line 82% versus 66%; 2+ lines 72% versus 60%. This presentation concluded that Kd should be considered in patients who have progressed on Rev maintenance. {Mon-729-P. Moreau}
  1. {Tourmaline-MM1} Phase III, n=722 relapsed/refractory multiple myeloma patients, Ixazomib (4mg days 1, 6, 15) +/- Rd [Ixazomib/Revlimid®/dex versus Revlimid®/dex (Rd)]. Note that 70% patients previously had VELCADE®, but were not refractory to Rev or proteasome inhibitors. Benefits seen in ORR (78% versus 72%, including CR 12% versus 7% and VGPR 36% versus 32%) and Median PFS (20.6 versus 14.7 months, including del17 21 months versus 10 months). Overall survival data not presented due to lack of maturity. {Mon-727-P. Moreau}
  1. {ASPIRE subgroup Analysis} Phase III, n=100 high-risk relapsed/refractory multiple myeloma patients. KRd versus Rd, where High-Risk is one of del 17p (>60% of plasma cells), t(4;14) or t(14;16). Median PFS for HR was 23 months versus 14 months (compared with standard risk 30 months versus 20 months). ORR from high-risk was 79% versus 60% (compared with standard risk 91% versus 74%). {Mon-731-H. Avet-Loiseau}
  1. A pooled analysis of three trials example the usage of pomalidomide and dexamethasone in 355 patients with moderate kidney involvement (versus 713 patients with no renal impairment. Similar ORR (30% versus 34%), median PFS (4 months versus 5 months) and median OS (11 months versus 14 months) as well as Grade 3/4 Adverse Effects. {Sun poster-3031-D. S. Siegel}

MAINTENANCE (including CONSOLIDATION)

  1. Phase III, n=1964 pooled analysis examined complete response (CR) patients who received maintenance or not, and determined a significant five-year OS benefit (80% versus 54%) and five-year PFS benefit (52% versus 19%) for patients on maintenance. {Sat poster-1974-C. Cerrato}

NEW DRUGS

  1. {Keynote-023} Phase I, n=17 relapsed/refractory multiple myeloma patients, including 50% refractory to Rev. Pembrolizumab (anti PD-l Antibody) + Rd. Pembro dose confirmed at 200mg. ORR 76% (including 56% for patients Rev-refractory), with 4 of 17 patients VGPR (24%). {Mon-505-Jesús F. San Miguel}
  1. Phase II, n=27 relapsed/refractory multiple myeloma patients, 36% high-risk, 90% Rev-refractory, 70% refractory to both IMiDs and proteasome inhibitors. Pembrolizumab (anti PD-l Antibody) + Pom-d. ORR 60% (including 55% for double-refractory and 50% high-risk). Gr3 AEs 10-20% pneumonia/infection. {Mon-506-A. Badros}
  1. Phase II, relapsed/refractory multiple myeloma patients, n=68. Carfilzomib +/- Filanesib (ARRY-520), a kinesin spindle protein (KSP) inhibitor. Adding FIL show some benefit: ORR 28% versus 24% and median PFS 9 months versus 4 months. {Mon-728-J. Zonder}
  1. Selinexor (KPT-330), which enhances the natural cell defenses against cancer, was combined with VELCADE® or Kyprolis® (carfilzomib) and shown to potentially overcome drug resistance. {Sunday poster-3048-D. Sullivan}. And when combined with Carfilzomib/dex (Cfz/d) in a phaseI trial, including those refractory to Cfz, >= Partial response was 75%, although results are still early. {Mon poster-4223-A. Jakubowiak}

OTHER RESULTS

  1. CAR-T therapy for myeloma treatment resulted in several oral presentations. In pre-clinical models, SLAMF7-CAR-T cell therapy was shown to be safe and effective in MM treatment. {Sat-115-S. Danhof}. And a biopharmaceutical company called Cellectis in France showed that they can use healthy donor T-cells and engineer them for a double knockout (both TRAC and SLAMF7) to enhance antitumor activity. {Sat-116-R. Galetto}. And a “Late-Breaking Abstract” highlighted a phase I study of 12 relapsed/refractory multiple myeloma patients using CAR-T cells engineered as anti-BCMA CARs (CAR-BCMA). The B-cell maturation antigen (BCMA) is expressed by normal and malignant plasma cells in 60-70% of MM patients. To participate in this National Cancer Institute trial, patients must have had three lines of prior therapy and BCMA expression. Patients were given three days of Cytoxin and fludarabine beforehand, but no transplant. All 12 patients achieved at least stable disease (SD) with 1 stringent complete response (sCR), one VGPR, and two PRs, and the results were typically better as dosages increased. Patients incurred substantial toxicity (fever, kidney, cytokine release, and more; but these adverse effects were all reversible. Still, a follow-up trial eligibility criteria will include patients have fewer than 50% plasma cells. {Tue-LBA-1-J. Kochenderfer}
  1. MRD was evaluated in the French side of the IFM/DCFI 2009 “Determination” trial. Of n=700 patients, 178 patients were evaluated by Next-Generation Sequencing after maintenance. For complete response patients, 83% were MRD-negative, but 17% were MRD-positive. {Sat-191-H. Avet-Loiseau}
  1. MRI & PET-CT were evaluated in the French side of the IFM/DCFI 2009 “Determination” trial. At diagnosis for n=134 patients, MRI and PET-CT scans were positive for 95% and 91% of patients. After three cycles of RVd, MRI was still positive in 93%. However, PET-CT scans were positive in only 55% and were a better prognostic indicator for PFS but not OS. Before maintenance, MRI was not a good prognostic indicator for PFS or OS, but PET-CT results were associated with significant improvement in both PFS and OS. As such, an MRI may not be needed for follow-up, while PET-CT scans should be part of follow-up. {Sun-395-P. Moreau}
  1. This study examined n=693 SCT patients who had various induction therapies RVd, Rd, Vd, and CVd, specifically at pre-SCT and post-SCT >= VGPR results. Pre-SCT responses were 57% versus 42% versus 51% versus 45% and post-SCT were 65% versus 63% versus 65% versus 58%, all quite close. However, maintenance treatment improved three-year PFS to 55% versus 39% for no maintenance. In conclusion, when having an SCT, the choice of induction treatment is less important than maintenance {Sun-396-R. F. Cornell}
  1. Ph 2, n=100 patients, 25 per arm. Isatuximimab (SAR650984) single agent at different dose/frequencies: Arm 1: 3mg/kg every other week (q2w); Arm 2: 10mg/kg q2w for 4 doses, then q4w; Arm 3: 10mg/kg q2w; Arm 4: 20mg/kg weekly x 4 dose then q2w. ORR: 9%, 20%, 29%, 24%. Gr 3 anemia in 20% of patients. {Mon-509-T. Martin}
  1. I attended a session on Patient-Reported Outcomes (PRO’s) which examine Physical, Mental and Social Health in clinical trials and patient care. PRO data is used by prescribers, regulators, and healthcare payers. You can learn more about this at healthmeasures.net and www.nihpromis.org.
  1. A Medicare cost study was done for 3000 MM patients that assessed the economic burden for both MM treatment costs and pharmacy antiMM cost PPPM (cost per-patient per-month) for treatment lines First ($14K, $3K). Second ($16K, $3K), and Third ($16K, $3K) in 2015 dollars. Average treatment duration was eight, six, and five months, respectively. {Sat poster-2100-C. Chen}
  1. I attended a meeting conducted by Takeda on the usage of their new oral PI Ninlaro (ixazomib). It’s indicated for patients who have had one prior treatment and used with Rev-d. It needs to be taken on an empty stomach (1 hr before or 2 hrs after a meal) to ensure efficacy. And while the standard dosage is a 4 mg capsule, it also comes in 3 mg and 2.3 mg capsules. The name Ninlaro? While in development, the drug was called MLN9708. So Ninlaro comes from Nine (minus the “e”), plus “oral” spelled backwards.
  1. A study examined Cytogenetic (CG) Progression for 130 patients over the course of their disease, taking bone marrow samples and looking for risk factors such as del 17p, t(14;16), t(14;20), t(4;14), del 13 and gain 1q21. Ninety (69%) of one-hundred-and-thirty patients had normal cytogenetics at diagnosis but 27% of these patients developed abnormal cytogenetics during disease course, resulting in shorter median OS (4 yrs) versus patients with normal cytogenetics (11.3 yrs) or even patients with any cytogenetic abnormality at diagnosis (7.4 yrs). Bone marrow biopsies/aspirates are important during the course of treatment. {Mon poster-4209-C. Pascal}
  1. A presentation on Social Media for Hematologists was titled “So You Know How to Treat, But Do You Know How to Tweet?” and discussed the increased usage of Twitter during ASH15 from more than 5K participants, including a number of support group leaders (SGL) in attendance. For a summary of all the SGL tweets, use the hashtag #IMFASH15.
  1. Palliative Care is a multidisciplinary approach to symptom management, psychosocial support, and assistance in treatment decision-making for both patients with serious illness and their families. Unlike Hospice, PC does not require either a terminal diagnosis or proximity to death.

In the US there are >6500 board-certified palliative medicine physicians and >18,000 certified non-physician palliative care professionals who work together with a patient’s other doctors to provide an extra layer of support. PC in the setting of SCT should be considered from the day of diagnosis and tied to need, not to prognosis. How do we balance the trade off in which life may be prolonged and cancer cured, but quality of life is poor? PC has particular relevance in oncology given recent studies which link PC to improved patient quality of life, improved survival, and decreased cost of care.

SUMMARY

For someone diagnosed with stage III MM 21 years ago with only two treatment options available — melphalen/predisone (MP) or vincristine/Adriamycin/dexamethasone (VAD)-SCT— and given two to three years expected survival, I’ve seen incredible progress since 2000, and especially this past year 2015. While there continue to be unanswered questions, we now have many more effective treatments for MM, providing patients with better opportunities to manage their disease.

GLOSSARY (according to Jack)

 

Drug Class/Category

IMID – Immunomodulatory Drug

PI – Proteasome Inhibitor

mAb – Monocloncal Antibody

Drugs (brand name)

C – Cyclophosphamide (Cytoxan)

Cfz – Carfilzomib (Kyprolis)

D – Daratumumab (Darzalex)

E – Elotuzumab (Empliciti)

I – Ixazomib (Ninlaro)

M – Melphalan

P – Prednisone

Pano – Panobinostat (Farydak)

Pom – Pomalidomide (Pomalyst)

R – (Lenalidomide) Revlimid

S – Isatuximab (SAR650984)

T – Thalidomide

V- Velcade (Bortezomib)

Treatment Success Measurements

EFS – Event-free Survival

ORR – Overall response (>=PR)

OS – Overall Survival

PD – Progressive Disease

PFS – Progression-free Survival

PFS2 – PFS + next-line treatment PFS

TTP – Time to Progression

TTR – Time to Respond

Treatment Response

CR – Complete Response: No sign of MM (0 M-spike)

nCR – Near CR (positive M-spike, may be same as VGPR)

MR – Marginal Response: 0-50% reduction in MM

PR- Partial Response: 50% reduction in MM

SD – Stable Disease i.e. no response but also not worse

sCR-Stringent CR: CR+ normal FLC & no clonal cells

VGPR – 90% reduction in MM

MRD – Minimum Residual Disease typically by Flow Cytometry (NGF) or DNA sequencing (NGS) to provide more accurate measure of MM.

 

Side Effects

AE (ASE) – Adverse Event (Adverse Side Effects)

DVT – Deep Vein Thrombosis (blood clots)

MTD – Maximum Tolerated Dose

ONJ – Osteonecrosis of the Jaw

PE – Pulmonary Embolism

PN – Peripheral Neuropathy

QOL – Quality Of Life

VTE – Venous Thromboembolism (PE + DVT)

 

Tests/When to treat?

CRAB – High Calcium, Renal, Anemia, and Bone…

CRABi – CRAB + “i” increased infections

FLC – Free Light Chain

SCT – Auto stem cell transplant.

“d” and “D” – Typically both mean Low-dose Dex (40 mg/week) these days

MGUS – Monoclonal Gammopathy of Undetermined Significance

SMM – Smoldering MM

R/R- Relapsed/Refractory Ref defined progressing while on Tx or within 60 days.

Follow Jack on Twitter: @JackMAiello
http://www.sfbayareamyelomasupport.org
San Francisco Bay Multiple Myeloma Support Group
Meeting locations vary throughout the SF Bay

 

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