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“HemoTalks” Webinar on “Optimising Outcomes for Multiple Myeloma Patients with Lenalidomide”

 

Webinar: 25th June 2020; Thursday

Key Note Speaker: Dr. Shaji K. Kumar, MD, is Consultant in the Division of Hematology and Professor of Medicine at Mayo Clinic Cancer Center in Rochester, Minnesota. He also serves as Medical Director for the Cancer Center Clinical Research Office, which oversees the development, activation, conduct, and monitoring of interventional trials across the three locations of Mayo Clinic Cancer Center.

Dr. Kumar’s research focuses on the development of novel drugs for the treatment of myeloma. He is the principal investigator of clinical trials exploring new drugs and combinations for newly diagnosed and relapsed myeloma. He has presented his research nationally and internationally and has contributed to numerous articles, abstracts, editorials, and letters in peer- reviewed publications. Dr. Kumar serves on the editorial boards for American Journal of Hematology, European Journal of Clinical and Medical Oncology, and Leukemia. He also serves as Co-Chair of the NCI Myeloma Steering Committee.

Dr. Kumar is Chair and Value Pathways Task Force Member of the NCCN Multiple Myeloma / Systemic Light Chain Amyloidosis / Waldenström's Macroglobulinemia Panel. He also is an editorial board member for JNCCN—Journal of the National Comprehensive Cancer Network and a member of the NCCN Quality and Outcomes Committee.

Chairperson: Dr. Ng Soo Chin, is Consultant Haematologist and Director of Clinical Diagnostic Laboratory at Subang Jaya Medical Centre, Malaysia.

Dr. Deepak CSN: Medical Affairs Team, Dr. Reddy’s Laboratories, India

Key Messages from the Webinar

  • Myeloma in Malaysia:
    • An uncommon malignancy
    • median age of 60 years- relatively younger age (median)of patient population compared with west
    • Igk is the common subtype and most patients present clinical manifestations of Bony involvement (>70%) or renal impairment (>70%) and >80% with ISS stage II & III disease
  • Lenalidomide: A Standard-of-Care in Multiple Myeloma:
    • Smoldering multiple myeloma:
      • Mateos et al, NEJM 2015: Data from a randomized Spanish trial suggest that lenalidomide (len)/dexamethasone improves time to developing myeloma (TTP) and overall survival for patients (pts) with high risk (HR) SMM over Observation, however, patients were not screened with advanced imaging techniques
      • E3A06: phase III trial of lenalidomide versus observation alone in patients with asymptomatic high-risk smoldering multiple myeloma: Lenalidomide significantly decreased the risk of progression.
      • Goals of Initial Therapy in multiple myeloma: The ideal initial therapy should: Rapidly and effectively control disease, Reverse disease related complications, Decrease the risk of early death, Be easily tolerated with minimal/manageable toxicity and Not interfere with stem cell collection if needed
    • SWOG S0777: VRd Versus Rd: addition of bortezomib to lenalidomide and dexamethasone resulted in significantly improved PFS & OS with an acceptable risk-benefit profile
      • mPFS was significantly improved in the VRd group (43 months vs 30 months in the Rd group; stratified hazard ratio [HR] 0·712, 96% CI 0·56-0·906; one-sided p value 0·0018).
      • The mOS was also significantly improved in the VRd group (75 months vs 64 months in the Rd group, HR 0·709, 95% CI 0·524-0·959; two-sided p value 0·025).
      • The rates of overall response (partial response or better) were 82% (176/216) in the VRd group and 72% (153/214) in the Rd group, and 16% (34/216) and 8% (18/214) of patients who were assessable for response in these respective groups had a complete response or better.
    • Lenalidomide has also demonstrated efficacy in combination with novel agents like Carfilzomib and Ixazomib.
    • Phase II GRIFFIN study: showed that adding daratumumab to lenalidomide, bortezomib and dexamethasone (D-RVd regimen) improves response rates and depth of response over time in patients with newly diagnosed multiple myeloma
    • EMN02/HO95 MM Trial: Upfront ASCT still remains the preferred treatment for younger NDMM patients
    • Lenalidomide maintenance:
      • At a median follow-up time of 79.5 months for all surviving patients, the median OS had not been reached for the lenalidomide maintenance group, whereas it was 86.0 months for the placebo or observation group (hazard ratio, 0.75; 95% CI, 0.63 to 0.90; P = .001).
      • meta-analysis demonstrates a significant OS benefit and confirms the PFS benefit with lenalidomide maintenance after ASCT in patients with NDMM when compared with placebo or observation
    • Impact of age: Co-morbidities (Hypertension, Ischemic heart disease, Diabetes, Renal insufficiency, Osteoporosis, Psychological issues), Frailty, Altered drug metabolism, Limited social support, financial issues, Limited independence/ mobility
    • Continuous Lenalidomide Treatment for NDMM: MPR-R significantly prolonged progression-free survival in patients with newly diagnosed multiple myeloma who were ineligible for transplantation, with the greatest benefit observed in patients 65 to 75 years of age
    • Lenalidomide and Dexamethasone in Transplant-Ineligible Patients with Myeloma: As compared with MPT, continuous lenalidomide–dexamethasone given until disease progression was associated with a significant improvement in PFS, with an OS benefit
    • RVD lite: reduction in the intensity of the RVD regimen, RVD lite, is a well‐tolerated and highly effective regimen, with robust PFS and OS, in the transplant‐ineligible MM population.
    • When should we start treatment for relapse:
      • Patients with clinical progression/ CRAB symptoms clearly needs treatment
      • Those with biochemical progression only may not need immediate treatment
      • Treatment indicated in: High risk disease with any progression, Presentation with renal or neurological complications and Rapid doubling of M spike
    • Factors influencing treatment selection: Prior drug exposure/ refractory status, High risk vs. standard risk, Age, frailty and comorbidity, Toxicity with prior drugs, Transplant eligibility/ prior transplant, Patient preference/ goals of care, Logistics of drug administration
    • POLLUX trial: daratumumab, lenalidomide and dexamethasone significantly lengthened progression-free survival among patients with relapsed or refractory multiple myeloma.
       
  • Optimizing Lenalidomide Use in MM
    • Common toxicities of Lenalidomide: Hematological toxicity, Skin rash, Venous thromboembolism, Muscle cramps, Diarrhea, Fatigue & Second malignancies
       
    • Hematologic Toxicity:
      • Lenalidomide can cause neutropenia and thrombocytopenia.
      • Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors
         
    • Thromboembolism:
      • Increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM.
      • Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking).
      • Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks.
         
    • Skin Rash:
      • Common side effect, typically in first cycle- Patchy, raised, macular skin lesions, often with localized urticaria
      • Mild-to moderate rash can be treated with antihistamines, topical corticosteroids
      • For grade 2 or 3 rash, dose interruption with restarting a lower dose usually effective
         
    • Diarrhoea: Often appears late, in maintenance phase. Symptomatic management typically sufficient, maintenance of hydration, use of bile sequestering agents may be considered

Secondary primary malignancies: An increase of hematologic plus solid tumour Secondary primary malignancies have been observed. Age appropriate screening and Careful monitoring for any symptoms is recommended