Phase 1 STOMP Trial for RRMM

EP: 1.Case Overview: 79-Year-Old Woman With Multiple Myeloma

EP: 2.Frontline Treatment Options for Multiple Myeloma

EP: 3.Second-Line Treatment Options for Multiple Myeloma

EP: 4.Phase 3 BOSTON Trial for RRMM

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EP: 5.Phase 1 STOMP Trial for RRMM

EP: 6.Role of Toxicity Management in RRMM

EP: 7.Future Treatment Landscape for RRMM

Clifton C. Mo, MD: The STOMP trial is an ongoing multicenter study with both dose escalation and dose expansion phases. It is looking at the safety and efficacy of selinexor when given in combination with multiple other FDA-approved multiple myeloma agents, including bortezomib, carfilzomib, pomalidomide, lenalidomide, and even the anti-CD38 monoclonal antibodies as well as even newer recently FDA-approved myeloma agents. This study is ongoing; however, we have reported data on multiple arms. The bottom line with what we’re seeing in the STOMP trial is essentially a capitulation of what we’ve seen with the BOSTON trial: there is significant activity in all arms of this study, and there is a good safety profile. Importantly, there is a very low rate of high-grade toxicities with the once-weekly selinexor dosing that’s part of the STOMP trial protocol as opposed to the previous twice-weekly dosing.

In terms of the tolerability of once-weekly selinexor, one good example from the STOMP trial would be the selinexor plus Pomalyst [pomalidomide] arm, or the selinexor, pomalidomide, dexamethasone [XPd] regimen. What we see so far in this arm of the study is a 0% incidence of high-grade, or grade 3/4, nonhematologic toxicity, so not just less than 10%, but 0%. Although the study is ongoing and although the patient populations of the STOMP and BOSTON trials are not identical to the patient population of the STORM trial, this is good evidence of not only improved tolerability but significantly improved tolerability of selinexor when given according to a once-weekly dosing schedule.

In terms of the patient we’re discussing today, most of us would seriously consider a triplet regimen. The daratumumab-containing regimens are probably the first thought on most of our minds, given the good efficacy and safety data with this type of approach, as well as our experience with it, quite frankly. Daratumumab has now been FDA approved for over 5 years. Most of us have become comfortable with giving it, so that’s going to be a commonly chosen regimen over the coming years. However, I don’t necessarily think that an anti-CD38 antibody-containing regimen is mandatory in the second-line setting. Other triplet regimens, including a selinexor-based regimen, should be given strong consideration. I would probably give especially strong consideration of this in patients who have cytogenetically high-risk disease, perhaps particularly in patients who have the 17p or TP53 deletion, given the encouraging efficacy data in this high-risk subgroup of patients that we see in the BOSTON study. It is something that should be considered.

Transcript edited for clarity.

Case: A 79-Year-Old Woman with Multiple Myeloma

Initial Presentation

• A 79-year-old woman presented with intermittent nausea, decreased appetite and tingling and numbness in her feet bilaterally
• PMH: HTN, medically controlled
• PE: thin, tired appearing woman, otherwise unremarkable; grade I peripheral neuropathy
• ECOG PS 0

Clinical Workup

• Labs: Hb 9.6 g/dL, calcium 10.5 mg/dL, LDH 210 U/L, creatinine 1.1 mg/dL, albumin 3.8 g/dL, beta-2 microglobulin 3.2 mcg/mL, M-protein 2.9 g/dL, serum free kappa light chains 4.4 mg/dL, CLCr 35mL/min
• Hepatitis B and C negative
• Skeletal survey and MRI showed a lytic lesion in her spine L3/L4
• Bone marrow shows 45% clonal plasma cells IgG k
• FISH: hyperdiploid
• Diagnosis: R-ISS stage I MM

Treatment

• Initiated lenalidomide + bortezomib + dexamethasone for 8 cycles + lenalidomide maintenance for 9 months
• Follow-up at that time revealed disease progression
• Initiated selinexor + bortezomib + dexamethasone