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A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with MM per International Myeloma Working Group (IMWG) criteria

Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2

Resolution of AEs from prior anti-cancer therapy to Grade <=1

Agreement to undergo scheduled assessments and procedures

Disqualifiers

Inability to comply with protocol-mandated hospitalization and procedures

History of confirmed progressive multifocal leukoencephalopathy

History of other malignancy within 2 years prior to screening

Current or past history of central nervous system (CNS) disease

Trial design

Design model

Sequential

Treatments tested in this trial

  • Cevostamab

    Drug

    Substudy 2: Cevostamab will be administered intravenously (IV) on a 28-day cycle, up to a total of 13 cycles. Substudy 4: Cevostamab will be administered by IV on a 21-day cycle, up to a total of 17 cycles.

  • Lenalidomide

    Drug

    Lenalidomide will be administered PO on days 1-21 of a 28-day cycle.

  • Tocilizumab

    Drug

    Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

  • Iberdomide

    Drug

    Iberdomide will be administered PO on days 1-14 of a 21-day cycle.

  • Dexamethasone

    Drug

    Dexamethasone will be administered on Days 2 and 8 of Cycles 1-3.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Substudy 2: Dose Escalation and ExpansionExperimental treatment 3 interventions
Group B: Substudy 4: Dose Escalation and ExpansionExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Stage 1: Percentage of Participants with Adverse Events (AEs)

Time frame
Baseline up to approximately 5 years
2

Stage 2: Objective Response Rate (ORR)

Time frame
Baseline up to approximately 5 years
3

Stage 2: Complete Response (CR) or Stringent Complete Response (sCR) Rate

Time frame
Baseline up to approximately 5 years
4

Stage 2: Rate of Very Good Partial Response (VGPR) or Better

Time frame
Baseline up to approximately 5 years

Secondary outcomes

1

Stage 1: Conversion to a Better Response

Time frame
Baseline up to approximately 5 years
2

Stage 1: PFS

Time frame
Baseline up to approximately 5 years
3

Stages 1 and 2: Duration of Response (DOR)

Time frame
Baseline up to approximately 5 years
4

Stage 1: OS

Time frame
Baseline up to approximately 5 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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