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Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) in patients with multiple myeloma (MM) who have received one to four prior lines of therapy and have been exposed to an anti-cluster of differentiation 38 (CD38) antibody, lenalidomide, a proteasome inhibitor (PI) and a B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to the start of administration of study treatment.

Received one to four lines of prior therapy, including prior B-cell maturation antigen (BCMA)-targeting Chimeric Antigen Receptors (CAR) T-cell therapy

Multiple Myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria

Is triple-class exposed, i.e. received anti- cluster of differentiation 38 (CD38) therapy, a proteasome inhibitor (PI) and lenalidomide in any prior line

Disqualifiers

Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)

Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/µL or 5% of the peripheral blood white cells

History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or known hypersensitivity to any of the excipients of cevostamab

Gastrointestinal (GI) disease that might significantly alter absorption of oral drugs

Trial design

Design model

Single group

Treatments tested in this trial

  • Cevostamab

    Drug

    Participants will receive cevostamab as per the schedule given in the protocol.

  • Pomalidomide

    Drug

    Pomalidomide will be administered as per the schedule given in the protocol.

  • Dexamethasone

    Drug

    Dexamethasone will be administered as a premedication as per the schedule given in the protocol.

  • Tocilizumab

    Drug

    Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Cevostamab plus Pomalidomide and Dexamethasone (Pd)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR) as assessed by an Independent Review Committee

Time frame
Up to approximately 3 years

Secondary outcomes

1

ORR, as assessed by the Investigator

Time frame
Up to approximately 3 years
2

Rate of Very Good Partial Response (VGPR) or Better

Time frame
Up to approximately 3 years
3

Complete Response/Stringent Complete Response (CR/sCR) Rate

Time frame
Up to approximately 3 years
4

Duration of Response (DOR)

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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