26 Participants NeededMy employer runs this trial

Elranatamab + Cyclophosphamide for Multiple Myeloma

Recruiting at 6 trial locations
AL
CR
Overseen ByCarlyn Rose Tan, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for individuals with multiple myeloma, a type of blood cancer that has returned or resisted previous treatments. The study aims to determine if combining elranatamab (an experimental treatment) with cyclophosphamide (a chemotherapy drug) proves more effective than elranatamab alone. Suitable candidates must have a confirmed diagnosis of multiple myeloma and have previously tried at least one other treatment. Participants should also possess certain risk factors that might influence their response to treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to understand any potential interactions or requirements.

Is there any evidence suggesting that the combination of elranatamab and cyclophosphamide is likely to be safe for humans?

Research has shown that the combination of elranatamab and cyclophosphamide is generally safe for patients with relapsed or refractory multiple myeloma, a type of blood cancer. In earlier studies, patients receiving elranatamab every two weeks experienced a reduction in severe side effects, from 58.6% to 46.6%. This indicates fewer serious problems occurred. Additionally, these tests revealed no new safety issues.

Cyclophosphamide, a common cancer treatment, has a well-known safety record. It may cause side effects like nausea or low blood cell counts, but these are usually manageable.

Overall, research suggests that this combination treatment is safe, with manageable side effects. However, individual experiences may vary, so discussing any concerns with a doctor is important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Elranatamab for multiple myeloma because it represents a novel approach compared to traditional treatments like proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies. Elranatamab is a bispecific antibody that targets both BCMA (B-cell maturation antigen) on myeloma cells and CD3 on T-cells, effectively directing the immune system to attack the cancer cells. This dual-targeting mechanism offers a new way to harness the body's own immune defenses, potentially leading to more effective and targeted treatment outcomes. Additionally, when paired with cyclophosphamide, a chemotherapy agent, the combination might enhance the overall therapeutic effect, offering hope for patients with this challenging condition.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Studies have shown that elranatamab can help people with relapsed or refractory multiple myeloma live longer without their cancer worsening. This period is called progression-free survival (PFS). Patients taking elranatamab experienced a much longer PFS compared to those who did not receive the treatment. In this trial, participants will receive a combination of elranatamab and cyclophosphamide to enhance these benefits. Elranatamab has also significantly reduced cancer cells in the body for an extended period. While more research continues, these results suggest that this combination could be promising for those who haven't had success with other treatments.14678

Who Is on the Research Team?

AL

Alexander Lesokhin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with multiple myeloma that has come back or not responded to treatment, who have certain risk factors like high levels of abnormal proteins in their blood or urine, a large number of cancer cells in the bone marrow, and visible bone or soft tissue lesions.

Inclusion Criteria

I have been diagnosed with multiple myeloma by a doctor.
* Serum M-protein ≥0.5 g/dL by SPEP
* Serum immunoglobulin free light chain ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (\<0.26 or \>1.65)
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of elranatamab and cyclophosphamide

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cyclophosphamide
  • Elranatamab

Trial Overview

The study is testing if combining elranatamab (an immune therapy) with cyclophosphamide (a chemotherapy drug) works better than elranatamab alone for treating difficult cases of multiple myeloma. All participants receive both drugs.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants with Multiple MyelomaExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

Phase 3 MagnetisMM-5 Results: Elrexfio Improves PFS in ...

Phase 3 MagnetisMM-5 trial results reveal Elrexfio (elranatamab) improves PFS in RRMM patients who received at least one prior line of ...

A Study of Elranatamab and Cyclophosphamide in People ...

To evaluate the complete response rate of elranatamab with cyclophosphamide in participants with relapsed or refractory multiple myeloma with adverse risk ...

Comparison of outcomes with elranatamab and real world ...

Patients with TCE MM have particularly poor outcomes, with median progression-free survival (PFS) in real world cohorts observed to be 4.6 to ...

Elranatamab Improves Survival in Phase 3 Trial for ...

Elranatamab-bcmm (Elrexfio) improved progression-free survival in a Phase 3 trial of relapsed or refractory multiple myeloma after at least 1 ...

Elranatamab + Cyclophosphamide for Multiple Myeloma

The purpose of this study is to find out whether the combination of elranatamab and cyclophosphamide is an effective treatment for people with ...

Elranatamab Exposure–Safety Analysis in Relapsed or ... - PMC

An exposure–safety analysis was conducted using the data from patients with RRMM across four clinical studies, MagnetisMM‐1, 2, 3, and 9 ( ...

A phase I/II, open label, Study to evaluate safety, tolerability ...

A retrospective case series demonstrated 100% overall response rate (ORR), including 65% complete responses (CR) and cardiac and renal responses ...

MM-1021: Efficacy and Safety of Less Frequent Dosing ...

Median (95% CI) PFS was 27.3 mo (4.3 mo–NE). Median (95% CI) OS was NR (14.9 mo–NE); the probability of survival at 30 mo (95% CI) was 55.8% (40.1%–68.9%). Any ...