The availability of effective therapies for multiple myeloma (MM) has sparked debate on the role of first line autologous stem cell transplantation (ASCT), particularly in standard-risk patients. However, treatment for individuals with high-risk disease continues to display suboptimal outcomes. With novel therapies used earlier, practice is changing rapidly in the field of MM. Presently, quadruplet induction therapy incorporating an anti-CD38 monoclonal antibody to a proteasome inhibitor and an immunomodulatory drug prior to ASCT followed by maintenance therapy stands as the foremost strategy for attaining deep and sustained responses in transplant eligible MM (TEMM). This Canadian Consensus Guideline Consortium (CGC) proposes consensus recommendations for the first line treatment of TEMM. To address the needs of physicians and people diagnosed with MM, this document focuses on ASCT eligibility, induction therapy, mobilization and collection, conditioning, consolidation, and maintenance therapy, as well as, high-risk populations, management of adverse events, assessment of treatment response, and monitoring for disease relapse. The CGC will periodically review the recommendations herein and update as necessary.

First Line Treatment of Newly Diagnosed Transplant Eligible Multiple Myeloma Recommendations from a Canadian Consensus Guideline Consortium

BACKGROUND
For patients with multiple myeloma (MM) who have undergone autologous stem cell transplant (auto-SCT), the immunomodulatory agent lenalidomide is a first-line option for maintenance therapy. Because longer durations of lenalidomide maintenance are associated with improved survival, identifying strategies to avoid premature cessation of maintenance is an important priority in the post-transplant setting.


OBJECTIVES
The primary objective of this analysis was to identify specific clinical predictors of lenalidomide treatment duration that could guide optimal medication management. Key secondary objectives included predictors of intolerable toxicity, rationale for lenalidomide dose reduction/discontinuation, and characterization of dose adjustments.


STUDY DESIGN
This retrospective, multi-center cohort study included adults with MM who underwent auto-SCT and initiated maintenance lenalidomide between 01/01/2012 and 02/28/2021. Variables assessed as potential predictors of maintenance duration or intolerable toxicity included age, body mass index (BMI), Eastern Cooperative Oncology Group (ECOG) performance status at time of auto-SCT, renal function, initial lenalidomide dose, use of combination maintenance therapy, and cytogenetic risk category.


RESULTS
Among 299 patients included, the median age at time of auto-SCT was 62 years (range 30-77). The majority of patients had standard-risk cytogenetics (64%) and an ECOG performance status of 0 or 1 (72%). In the overall population, the median duration of maintenance was 1.3 years (range 0.3-8.6 years). The median initial dose of lenalidomide was 10 mg daily (range 2.5-25 mg). During the study period, 35% of patients had a dose reduction due to toxicity, 21% stopped lenalidomide due to disease progression, and 19% stopped due to toxicity. Multivariate linear regression analyses did not identify any significant predictors of lenalidomide duration or discontinuation due to intolerable toxicity. The most frequently reported toxicities leading to discontinuation were cytopenias, rash, and fatigue.


CONCLUSION
This analysis did not identify any significant risk factors to predict the duration of lenalidomide maintenance or discontinuation for toxicity following auto-SCT in patients with MM. While limited by the retrospective design and relatively small sample size, our findings suggest that a priori lenalidomide dose reductions based on patient co-morbidities or performance status may not substantially affect the duration of lenalidomide maintenance.

Predictors of lenalidomide maintenance duration after autologous stem cell transplant in patients with multiple myeloma.

Phase II Study of the Combination of Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone in Early Relapsed/Refractory Multiple Myeloma

e20028 Background: Multiple myeloma (MM) is a disease predominantly of older adults with an average age of 69 at diagnosis. Limited data is available on the diagnostic details and outcomes of MM patients ≤50 years old, and particularly how these trends have changed over the past two decades. We present data from one of the largest retrospective cohorts of younger MM patients. Methods: This retrospective review identified 213 MM patients by pooling two datasets: 88 MM patients aged ≤50 years at first stem cell transplant (SCT) between 1/1/2000-6/1/2021 at University of California (UC), San Diego; and 125 MM patients age ≤50 years old at diagnosis between 1/1/2014-7/1/2021 at UC Davis. Demographics, diagnostic details, treatment, response, and overall survival (OS) data were collected. Results: The pooled dataset included 209 patients with MM and 4 with plasma cell leukemia. The median age was 45, with 58 (27%) Hispanic and 37 (17%) Black patients. In 89 patients with available data, 23% were R-ISS-1, 58% were R-ISS-2, and 19% were R-ISS 3. Overall, 14% of patients had high-risk cytogenetics [ t(4;14), del17p, or t(14;16]] . Patients diagnosed and treated in 2000-2010 were more likely to have received doublet or cytotoxic chemotherapy for induction therapy, while 80% of patients in 2010-2021 received triplet-based therapies. Responses to induction improved across decades, with 23% of patients in the earlier cohort vs 49% patients in the later cohort achieving a very good partial response (VGPR) or better. Eighty-five percent of patients received a SCT, the majority being autologous with only 13 upfront or salvage allogeneic SCTs in the earlier and 1 in the later cohort. The median OS for the entire cohort is 168 months, 171 months in the early cohort, and not reached in 2011-2021 cohort. Conclusions: We present retrospective data of a large and diverse cohort of California MM patients ≤50 years old, with nearly 50% of patients from underrepresented populations spanning over 2 decades. We found similar diagnostic features and risk group to those reported in the general MM population. Noticeable improvements in treatment responses were seen in the later decade with the introduction of modern therapies. A median OS of 14 years for the entire cohort over 20 years offers a glimpse into the hopeful promise for extended survival of younger patients as more effective therapies lead to deeper and more durable responses. [Table: see text]

Trends in presentation, treatment, and survival in young multiple myeloma patients age 50 and under from 2000-2021.

e20058 Background: AL amyloidosis is plasma cell disorder involving irreversible deposition of amyloid fibrils, leading to end-organ damage. Treatment strategies include systemic therapy, autologous stem cell transplant (ASCT), and organ transplant. The ANDROMEDA trial established daratumumab (Dara) in combination with cyclophosphamide, bortezomib (Bor), and dexamethasone (CyBorD) as a new standard of care in newly diagnosed AL amyloidosis. Notably, only 2% of the trial population had stage IIIB cardiac disease by Mayo 2004 criteria. We present real world data of orthotopic heart transplantation (OHT) recipients with AL amyloidosis at our institution to understand the safety and outcomes of Dara use in the setting of advanced cardiac involvement. Methods: We performed a retrospective review of 9 patients at our institution who had received OHT since 2019 for AL amyloidosis. Demographics, disease details, treatment selection, response, and outcomes data were collected and described. Results: The cohort included 22% Black and 22% Hispanic patients, and the median age at diagnosis was 56. All patients had Revised Mayo stage 3 or 4 disease with advanced cardiac involvement requiring OHT. Patients had a median of 3 (2-4) suspected organs involved; none had symptomatic myeloma. Four patients received induction CyBorD; 2 achieved complete response (CR), 1 very good partial response (VGPR), and 1 partial response (PR) prior to OHT. Three of 4 received bridging therapy (Dara-Bor triplet or Bor alone) prior to ASCT, 2 due to inadequate response and 1 to maintain CR, and all achieved CR post-ASCT. Median time from OHT to ASCT was 13.5 months (range: 8-17), with bridging therapy starting at a median of 6 months post-OHT if received, with concomitant reduction in OHT immunosuppression. Five patients received DaraCyBorD induction: 2 achieved CR, 2 achieved VGPR, and 1 achieved PR prior to OHT. No patient who received DaraCyBorD received ASCT. Those not in CR received further therapy post-OHT. At the time of this analysis, 89% of patients remain in CR with 2 receiving ongoing therapy. All patients are alive with a median follow-up of 22 months (range: 11-35) since OHT without evidence for organ rejection. Conclusions: We demonstrate that the use of subcutaneous Dara is tolerable and effective in advanced stage cardiac AL amyloidosis, an underrepresented group in the literature. Patients who received DaraCyBorD followed by OHT without ASCT achieved similar outcomes to those who received CyBorD, OHT, and ASCT. The routine use of Dara may therefore negate the need for ASCT in this setting, given its favorable toxicity profile and reduced cost. [Table: see text]

Management and outcomes of advanced stage cardiac AL amyloidosis in the daratumumab era.

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Papers

Predictors of lenalidomide maintenance duration after autologous stem cell transplant in patients with multiple myeloma.

Phase II Study of the Combination of Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone in Early Relapsed/Refractory Multiple Myeloma

Trends in presentation, treatment, and survival in young multiple myeloma patients age 50 and under from 2000-2021.

Management and outcomes of advanced stage cardiac AL amyloidosis in the daratumumab era.