What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, especially monoclonal and bispecific antibodies like Cevostamab, often cause hematologic toxicities such as neutropenia, lymphocytopenia, and anemia. Infections, including bacterial, viral, and fungal, are also prevalent. Specific treatments like daratumumab and elotuzumab are linked to higher rates of pneumonia, herpes zoster, and other opportunistic infections. Other side effects include infusion reactions, fatigue, gastrointestinal issues, and respiratory complications.

What prior FDA approvals exist?

Several FDA-approved treatments for Multiple Myeloma include bispecific antibodies and other novel agents targeting specific antigens. For instance, teclistamab, a bispecific T cell engager targeting BCMA and CD3, has shown promising results. Other notable treatments include anti-CD38 monoclonal antibodies like daratumumab and isatuximab, which target CD38 on myeloma cells. Additionally, chimeric antigen receptor (CAR) T cell therapies such as idecabtagene vicleucel and ciltacabtagene autoleucel target BCMA and have been approved for relapsed or refractory Multiple Myeloma. These therapies, like Cevostamab, aim to engage the immune system to target and kill myeloma cells.

What other types of research exist?

Promising novel alternatives to Cevostamab for Multiple Myeloma patients include: <ol> <li>Daratumumab: An anti-CD38 monoclonal antibody, often used in combination with other agents like lenalidomide and dexamethasone.</li> <li></li> </ol> Isatuximab: Another anti-CD38 monoclonal antibody, used in combination with pomalidomide and dexamethasone. 3. Elotuzumab: An anti-SLAMF7 monoclonal antibody, used in combination with lenalidomide and dexamethasone. 4. Venetoclax: A BCL-2 inhibitor, particularly effective in patients with t(11;14) translocation. 5. CAR T-cell therapies: Such as idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), which target BCMA (B-cell maturation antigen).

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Monoclonal Antibodies

Cevostamab for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have relapsed or refractory (R/R) multiple myeloma (MM) for which no established therapy for MM is appropriate and available or be intolerant to those established therapies

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Must not have

Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first cevostamab infusion

History of autoimmune disease or of confirmed progressive multifocal leukoencephalopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing cevostamab, a medication given through an IV drip, in patients with multiple myeloma that has returned or didn't respond to other treatments. The drug helps the immune system kill cancer cells. Cevostamab is currently under investigation for its potential to treat multiple myeloma.

Who is the study for?

This trial is for adults with relapsed or refractory multiple myeloma who have tried other treatments without success, are not pregnant or breastfeeding, and can perform daily activities with minimal assistance. They must not have had certain recent treatments, transplants, major surgeries, infections including COVID-19 within specific time frames, a history of severe allergies to monoclonal antibodies, or any condition that could interfere with the study.

What is being tested?

The study tests different doses of Cevostamab given through IV infusion to see how safe it is and how well it works in treating multiple myeloma that has come back or hasn't responded to treatment. Tocilizumab may also be used if needed. It's an early-phase trial where researchers closely monitor participants' reactions.

What are the potential side effects?

Possible side effects include allergic reactions to the drug components which might cause symptoms ranging from mild skin rashes to more serious issues like difficulty breathing. Other potential side effects are not specified but generally could involve typical chemotherapy-related issues such as fatigue, nausea, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My multiple myeloma has returned or hasn't responded to treatment, and I can't use or tolerate standard therapies.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer treatment in the last 4 weeks or within 5 half-lives of the drug.

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I have a history of autoimmune disease or a brain infection.

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I have or had a brain disease or my multiple myeloma has spread to my brain.

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I have heart problems that could affect my response to a severe reaction.

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I need extra oxygen because of my lung condition.

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I had a stem cell transplant using my own cells less than 100 days ago.

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I have had a previous transplant of bone marrow or an organ.

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I have been diagnosed with amyloidosis confirmed by a tissue biopsy.

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I have a history of HLH or MAS.

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I have a positive test for EBV or CMV.

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I have or might have a long-term EBV infection or hepatitis C.

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I have not had major surgery in the last 4 weeks.

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I am HIV positive.

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I have not had symptomatic COVID-19 or needed IV treatment for it in the last 14 days.

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I have had side effects from previous immune therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arms E and J Only: Incidence and Severity of Cytokine-release Syndrome (CRS) Following Tocilizumab Premedication Followed by Treatment with Cevostamab

Percentage of Participants With Dose-Limiting Toxicities (DLTs)

Percentage of Participants with Adverse Events (AEs)

Secondary study objectives

AUC of Tocilizumab

Area Under the Concentration-Time Curve (AUC) of Cevostamab

CL of Tocilizumab

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

11Treatment groups

Experimental Treatment

Group I: Arm K: Compressed Double Step Dose Expansion for CevostamabExperimental Treatment1 Intervention

In Cycle 1, participants will receive 2 step-up doses and a target dose. The doses will be given on Cycle 1 Days 1, 4, and 8. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.

Group II: Arm J: Expansion Phase for Tocilizumab PretreatmentExperimental Treatment2 Interventions

All participants will receive a single dose of tocilizumab intravenously. An additional dose of tocilizumab may be instituted as premedication for subsequent Cycle 1 dose(s) of cevostamab and Cycle 1 cevostamab doses for other treatment arms.

Group III: Arm I: Triple Step Dose Expansion for CevostamabExperimental Treatment1 Intervention

The triple step dose expansion stage of the study may use the dosing and assessment schedule from the triple step dose escalation arm in Cycle 1, based on data from Arm H.

Group IV: Arm H: Triple Step Dose Escalation for CevostamabExperimental Treatment1 Intervention

In Cycle 1, participants will receive 3 step-up doses and a target dose. The doses will be given on Cycle 1 Days 1, 2-4, 8, and 9-11. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.

Group V: Arm G: Double Step Dose Expansion for CevostamabExperimental Treatment1 Intervention

The double step dose expansion stage of the study may use the dosing and assessment schedule from the double step dose escalation arm in Cycle 1, based on data from Arm B.

Group VI: Arm F: Single Step Dose Expansion for CevostamabExperimental Treatment1 Intervention

The single step dose expansion stage of the study may use the dosing and assessment schedule from the single dose escalation arm in Cycle 1, based on data from Arm A.

Group VII: Arm E: Expansion Phase for Tocilizumab PretreatmentExperimental Treatment2 Interventions

Group VIII: Arm D: Double Step Dose Expansion for CevostamabExperimental Treatment1 Intervention

The double step dose expansion stage of the study may use the dosing and assessment schedule from the double step dose escalation arm in Cycle 1, based on data from Arm B.

Group IX: Arm C: Single Step Dose Expansion for CevostamabExperimental Treatment1 Intervention

The single step dose expansion stage of the study may use the dosing and assessment schedule from the single dose escalation arm in Cycle 1, based on data from Arm A.

Group X: Arm B: Double Step Dose Escalation for CevostamabExperimental Treatment1 Intervention

In Cycle 1, participants will receive 2 step-up doses and a target dose. The step-up dose will be given on Cycle 1 Day 1 and C1D8. The target dose will be given on C1D15. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.

Group XI: Arm A: Single Step Dose Escalation for CevostamabExperimental Treatment1 Intervention

Study drug will be administered intravenously on a 21-day cycle. The step-up dose will be given on Cycle 1 Day 1 and the target dose will be given on C1D8. Subsequently the target dose will be administered on Day 1 of each 21-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments often involve immunotherapies that harness the body's immune system to target and kill cancer cells. Bispecific antibodies, like Cevostamab, are designed to bind to two different antigens simultaneously—one on the myeloma cell (e.g., FcRH5) and one on T cells (e.g., CD3)—thereby bringing T cells into close proximity with myeloma cells to facilitate their destruction. Monoclonal antibodies, such as daratumumab and isatuximab, target specific proteins on myeloma cells to mark them for immune system attack. CAR T-cell therapies involve modifying a patient's T cells to express receptors that specifically target myeloma cells. These treatments are crucial for Multiple Myeloma patients as they offer targeted approaches that can lead to deep and durable responses, especially in cases where the disease is refractory to conventional therapies.

Myeloma: next generation immunotherapy.