Linvoseltamab for Multiple Myeloma

(RECLAIM Trial)

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Disqualifiers: Neurodegenerative condition, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 15 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of linvoseltamab for individuals with multiple myeloma, a type of blood cancer. It targets those whose cancer has returned after receiving BCMA CAR T-cell therapy, an advanced treatment using modified immune cells. Participants will receive linvoseltamab, a new potential drug, through an IV on a set schedule. Suitable candidates have undergone BCMA CAR T-cell therapy at least six months prior and still show measurable signs of cancer. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that linvoseltamab is likely to be safe for humans?

Research has shown that linvoseltamab is generally safe for patients with multiple myeloma. Studies have found that linvoseltamab can produce strong and lasting positive effects, with most patients tolerating it well. Specifically, recent data indicate that a 200 mg dose not only offers long-term benefits but is also safe for patients whose multiple myeloma has returned or not responded to other treatments.

Although linvoseltamab remains under study, the safety results so far are promising. It is important to note that more safety information is being collected, and ongoing trials aim to confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Linvoseltamab is unique because it targets multiple myeloma differently than existing treatments like proteasome inhibitors and immunomodulatory drugs. It works by specifically targeting a protein on the surface of myeloma cells, which may enhance its ability to fight the cancer more directly. Plus, the dosing regimen of linvoseltamab is designed to steadily increase its presence in the body, potentially leading to more effective control of the disease over time. Researchers are excited about its potential to offer a new option for patients, especially those who have not responded well to current therapies.

What evidence suggests that linvoseltamab might be an effective treatment for multiple myeloma?

Studies have shown that linvoseltamab effectively treats relapsed or hard-to-treat multiple myeloma. In one study, 71% of patients responded to the treatment, and 50% achieved a complete response, with all signs of cancer disappearing. Another study demonstrated high response rates even in high-risk patients. Linvoseltamab is considered a strong option for patients who have already tried other treatments. This evidence suggests linvoseltamab could be a promising choice for those with difficult-to-treat multiple myeloma. ^{2 6 7 8 9}

Who Is on the Research Team?

Meera Mohan, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for adults over 18 with multiple myeloma who've had BCMA CAR T-cell therapy at least 6 months ago. They must have measurable disease, be in fair to good health (ECOG 0-3), and able to consent. Some may join if less than 6 months post-therapy but meet specific conditions.

Inclusion Criteria

I had BCMA CAR T-cell therapy over 6 months ago as my last treatment.

I am 18 years old or older.

Must have measurable disease for response assessment as per the IMWG response assessment criteria

Exclusion Criteria

I do not have severe heart issues like recent heart attacks or very low heart pump function.

Known to be human immunodeficiency virus (HIV) positive

I do not have any serious health or mental conditions that could stop me from completing treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Linvoseltamab is administered in a step-up dosing regimen during the first two weeks, followed by weekly and bi-weekly dosing until Week 24, and then every four weeks until disease progression

Up to 15 months

Weekly visits initially, then bi-weekly, and monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Linvoseltamab

Trial Overview The study tests linvoseltamab's effectiveness and safety in patients whose multiple myeloma returned after BCMA CAR T-cell treatment. It's a phase 2 trial, meaning it focuses on the drug’s efficacy, with participants all receiving linvoseltamab.

How Is the Trial Designed?

Group I: Linvoseltamab Administration Experimental Treatment 1 Intervention

Linvoseltamab intravenous (IV) will be initially administered to all patients as a step-up dosing regimen during the first two weeks of Cycle 1 (Weeks 1 and 2; 5 mg on Cycle 1 Day 1 and 25 mg on Cycle 1 Day 8) in an inpatient setting. Starting with Cycle 1 Day 15 (Week 3), linvoseltamab 200 mg will be administered once a week until the end of Cycle 3 (Week 12) followed by once every two weeks (Days 1 and 15) during Cycles 4 through 6 (Weeks 13 through 24). From Cycle 7 Day 1 (Week 25) until disease progression, linvoseltamab 200 mg will be administered once every four weeks.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/7012/527741/Comparative-Effectiveness-of-Linvoseltamab-Versus

Comparative Effectiveness of Linvoseltamab Versus Current ... High objective response rates (ORR) to linvoseltamab 200 mg in the LINKER-MM1 trial (NCT03761108) were demonstrated across high-risk subgroups, ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.24.01008

Linvoseltamab for Treatment of Relapsed/Refractory ... At a median follow-up of 14.3 months, the ORR was 71%, with 50% achieving ≥complete response (CR). In 104 patients treated with 50 mg at a ...

3. onclive.com onclive.com/view/linvoseltamab-adds-highly-effective-option-in-later-line-multiple-myeloma

Linvoseltamab Adds Highly Effective Option in Later-Line ... “This approval provides a highly effective, off-the-shelf agent for the treatment of [patients with] relapsed/refractory multiple myeloma,” Lee ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38879802/

Linvoseltamab for Treatment of Relapsed/Refractory ... At a median follow-up of 14.3 months, the ORR was 71%, with 50% achieving ≥complete response (CR). In 104 patients treated with 50 mg at a ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2152265025002228

Indirect Comparison of Linvoseltamab Versus Teclistamab ... The analysis showed that linvoseltamab may offer improved efficacy over teclistamab for patients with TCE RRMM. These comparative data can help ...

6. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/3369/532700/Linvoseltamab-in-Patients-with-Relapsed-Refractory

Linvoseltamab in Patients with Relapsed/Refractory Multiple ... Linvoseltamab induced deep and durable responses with an acceptable safety profile in patients with relapsed/refractory multiple myeloma (RRMM) ...

7. onclive.com onclive.com/view/linvoseltamab-yields-favorable-safety-profile-and-antimyeloma-activity-in-high-risk-smoldering-myeloma

Linvoseltamab Yields Favorable Safety Profile and ... Linvoseltamab-gcpt showed a 100% overall response rate in high-risk smoldering multiple myeloma patients, with significant MRD negativity rates.

8. investor.regeneron.com investor.regeneron.com/node/29866/pdf

Updated Linvoseltamab Data Showcase Continued ... Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

9. bloodcancerstoday.com bloodcancerstoday.com/post/linvoseltamab-shows-prolonged-efficacy-and-safety-in-high-risk-relapsed-or-refractory-mm

Linvoseltamab Shows Prolonged Efficacy and Safety in ... Updated LINKER-MM1 data show linvoseltamab 200 mg delivers lasting responses and survival in relapsed/refractory multiple myeloma, ...