380 Participants NeededMy employer runs this trial

Cevostamab + Pomalidomide + Dexamethasone for Multiple Myeloma

(CEVOLUTION Trial)

Recruiting at 75 trial locations
RS
RS
Fr
Overseen ByFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Hoffmann-La Roche
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 for people with multiple myeloma, a type of blood cancer, who have already tried one to three treatments. The researchers aim to determine if adding cevostamab (an experimental treatment) to pomalidomide and dexamethasone is more effective than standard treatments. Participants should have multiple myeloma and have previously received treatments such as anti-CD38 and lenalidomide. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

Do I need to stop my current medications for the trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that the combination of cevostamab, pomalidomide, and dexamethasone caused some side effects. Serious side effects occurred in 60% of patients, and 96% experienced severe side effects, classified as grade 3 or 4. One report noted a grade 5 side effect, the most severe. Despite these numbers, researchers considered the treatment generally manageable for patients. This combination has shown promise, especially for those who have not responded to other treatments for multiple myeloma. Always consult a healthcare professional to understand what these side effects might mean.12345

Why do researchers think this study treatment might be promising for multiple myeloma?

Unlike the standard treatments for multiple myeloma that primarily target cancer cells directly, Cevostamab brings something new to the table. It employs a unique mechanism by targeting both the BCMA on myeloma cells and CD3 on T-cells, effectively bridging the immune system to fight the cancer more efficiently. Researchers are excited about this approach because it could enhance the body's natural defenses, offering a potentially powerful new tool against multiple myeloma beyond traditional therapies like lenalidomide and bortezomib. Additionally, the combination with Pomalidomide and Dexamethasone aims to optimize the immune response and improve treatment outcomes.

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

In this trial, participants will receive either the combination of cevostamab with pomalidomide and dexamethasone or a standard care regimen. A previous study showed that this combination achieved promising results for treating multiple myeloma, with an overall response rate of 86.2%, indicating that most patients experienced tumor reduction or remission. Another study found that this combination led to very good partial responses or better in 81.3% of patients. These findings suggest that cevostamab, when combined with pomalidomide and dexamethasone, could be highly effective for individuals with multiple myeloma who have tried other treatments.13467

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma who have already had 1–3 previous treatments, including both an anti-CD38 antibody and lenalidomide. Participants must be able to care for themselves or only need help due to myeloma symptoms like pain, and their disease must be measurable at screening.

Inclusion Criteria

I have a tumor or lesion that can be measured by scans or tests.
I have been diagnosed with multiple myeloma by standard criteria.
I am fully active or have only minor limitations in daily activities.
See 2 more

Exclusion Criteria

I do not have active brain disease or non-secretory myeloma.
I have a digestive condition that affects how I absorb oral medications.
I have been diagnosed with amyloidosis.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cevostamab in combination with pomalidomide and dexamethasone or standard of care

Up to 5 years
Cevostamab administered on a 21-day cycle initially, then 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cevostamab
  • Dexamethasone
  • Pomalidomide

Trial Overview

The study compares a new combination of cevostamab, pomalidomide, and dexamethasone (CevosPd) against standard treatments such as daratumumab, elotuzumab, or carfilzomib in people with previously treated multiple myeloma. Patients are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Cevostamab + Pomalidomide + DexamethasoneExperimental Treatment3 Interventions
Group II: Standard of Care (SOC)Active Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

Cevostamab Plus Pomalidomide/Dexamethasone Is Safe ...

For patients in the 70-mg cohort, the overall response rate (ORR) was 86.2% (95% CI, 71.9%-100%). The rates of stringent complete response (sCR) ...

Study Details | NCT07555938 | Cevostamab in ...

The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of ...

PB2034: CAMMA 1: A MULTICENTER PHASE IB TRIAL ...

Clinical data from the first-in-human Phase I study (GO39775) suggest that cevostamab monotherapy is highly active in heavily pre-treated patients with R/R MM, ...

Cevostamab in Triplet Regimen for Multiple Myeloma

In the 70-mg cohort, the objective response rate was 93.8%, and the rate of very good partial response or better achieved by patients was 81.3%; ...

Cevostamab in combination with pomalidomide ... - Medically

Cevostamab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma: updated Phase I safety run-in results ...

NCT04910568 | A Study Evaluating the Safety, ...

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy.

camma 1 / nct04910568

"Cevostamab: Clinical and exploratory biomarker analysis from the phase Ib CAMMA-1 study shows investigational cevostamab in combination with pomalidomide and ...