My experience in High Risk MGUS & Non High Risk SMM trial

Posted by righty01 @righty01, 4 days ago

I am currently enrolled in a clinical trial sponsored by Regeneron Pharmaceuticals. It is a Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients with High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma.

About me. I was first diagnosed with MGUS in the Winter of 2024. M-Spike.6 and elevated Lambda FLC of 118. Referred to a local oncologist who scheduled quarterly bloodwork. Both M-spike and Lambda flc increased modestly with each draw. November 2025 my m spike was 1.6 and lambda flc 375 with kappa lambda flc ratio of 18.1.

BMB done 1/2026. 10-15 % plasma cell percentage with gain of 1q, monosomy 13 and deletion of 16q.

Referred to Dana Farber in Boston. Enrolled in their clinical trial 24-135. Randomized into high dose track, 200 mg of the study drug Linvoseltamab .

I have IGG Lambda intermediate SMM. IGG is 2375, M-Spike is 1.8 and kappa lambda flc ratio is 28.1 at the start.

I just had my second step up infusion, 4 mg, last week. Third step up dose, 25 mg, scheduled for this Wednesday. First full dose, 200 mg, with be on 8/10. I received steroid and antihistamine prior to each infusion.

Would like to share my journey with anyone interested or in a similar situation.

Only side effects to date are a little sleep disruption I believe from the steroid , dexamethasone 40 mg.

Interested in more discussions like this? Go to the Blood Cancers & Disorders Support Group.

Ginger, Volunteer Mentor | @gingerw | 3 days ago

@righty01 Thank you for participating in this medical trial! That's the best way for new treatment options to become an approved protocol.

I hope you will come back and let us know more about your journey on this?
Ginger

kjoed53 | @kjoed53 | 3 days ago

I didn't realize there was a high risk MGUS, but I wasn't diagnosed until I had SMM. Unfortunately for me I was on 25mg prednisone for PMR when I had my bone marrow biopsy, so my actual risk is still undetermined. I'm at 5mg now and scheduled for new blood work tomorrow. Keep posting. I'm definitely interested in knowing the results.

righty01 | @righty01 | 2 days ago

In reply to @kjoed53 "I didn't realize there was a high risk MGUS, but I wasn't diagnosed until I had..." + (show)

@kjoed53

It is interesting you mention PMR. I was experiencing bilateral knee, hip and shoulder pain in the fall of 2023. Had a battery of bloodwork over the next 6 months to try to figure it out. That is hoe I was initially diagnosed with MGUS.

I was finally diagnosed with PMR in the Spring of 2024.

gweiman | @gweiman | 2 days ago

I have a very similar history with MGUS and SMM. Like you my only “treatment” is quarterly blood draws so I’m very interested in your experience in this trial to see if there’s actually something that can be done.
Thank you for your willingness to participate and please keep us all informed.

hsminc | @hsminc | 2 days ago

I never heard of high risk MGUS either. My numbers certainly exceed or equal yours (also IgG lambda (1.6) (3375) - but my oncologist thinks I am reasonably stable - have been for 24 years. (I have worried about this for 24 years.)
We are all hoping for this trial to be successful. What can you tell us about this new drug????

kjoed53 | @kjoed53 | 2 days ago

In reply to @righty01 "@kjoed53 It is interesting you mention PMR. I was experiencing bilateral knee, hip and shoulder pain..." + (show)

@righty01
My rheumatologist suspected PMR but he is known for ordering extensive blood work and he caught the blood disorder markers too. He sent me to a hematologist oncologist for further evaluation. It entirely possible and probable that I had undiagnosed MGUS before PMR and before progression to SMM

righty01 | @righty01 | 2 days ago

In reply to @hsminc "I never heard of high risk MGUS either. My numbers certainly exceed or equal yours (also..." + (show)

@hsminc
Linvoseltamab is a FDA approved immunotherapy drug used to treat relapsed or refractory multiple myeloma. Approved for adults who have already received at least four prior therapy lines. Clinical trial is to see if it can delay progression.

I believe I am intermediate SMM because my kappa lambda free light chain ratio is greater than 20. My plasma cell percentage is 10-15 % and my FISH panel showed gain of 1Q and monosomy 13 which apparently puts me on a faster track to progression.

I am cautiously optomistic.

maddogstormy | @maddogstormy | 2 days ago

In reply to @righty01 "@hsminc Linvoseltamab is a FDA approved immunotherapy drug used to treat relapsed or refractory multiple myeloma...." + (show)

@righty01
Congratulations on being a participant in the trial.
I wish you well with the trial. I am finished with the treatment as of June 2. Numbers are way down. I have been designated CR and am not yet MRD negative. My bone marrow biopsy showed some remaining cellular presence. Linvoseltamab has a very long half life and I am hoping the biopsy in November will show no cells.

kayabbott | @kayabbott | 16 hours ago

There are a number of clinical trials for SMM now, at least for high risk. Info and links are at ClinicalTrials.gov.

Please sign in or register to post a reply.