A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma

ConditionMultiple Myeloma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorMemorial Sloan Kettering Cancer Center

About this trial

The researchers are doing this study to find out whether combining teclistamab and mezigdomide is a safe and effective treatment approach in people with relapsed/refractory multiple myeloma (MM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with relapsed or refractory multiple myeloma who have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. Patients who have been treated with at least 2 prior lines of therapy are eligible. Multiple myeloma is defined by the International Myeloma Working Group (IMWG) updated criteria.

Serum myeloma (M)-protein greater than or equal to 0.5 g/dL (5 g/L).

Urine M-protein greater or equal to 200 mg/24 h.

Involved light chain (either kappa or lambda) >10 mg/dL with an abnormal kappa: lambda ratio

Disqualifiers

Prior treatment with a BCMA targeted bispecific antibody

Prior treatment with mezigdomide

Systemic anti-myeloma therapy (including systemic steroids) within ≤14 days, or plasmapheresis within 7 days prior to the first dose of study drug.

Use of an investigational drug within 21 days or five half-lives (whichever is longer) preceding the first dose of study drug.

Trial design

Design model

Sequential

Treatments tested in this trial

Teclistamab
Drug
After the priming, patients will start Teclistamab step up dosing. Mezigdomide will not be given during the Teclistamab step up. After the priming and step-up, patients will start combination treatment with Teclistamab and Mezigdomide.
Mezigdomide
Drug
Start with 14 days of Mezigdomide. After the priming and step-up, patients will start combination treatment with Teclistamab and Mezigdomide.

Treatment groups

18 Participants

are divided into 3 treatment groups

Group A: Phase I: Teclistamab and 0.6 mg MezigdomideExperimental treatment 2 interventions

Group B: Phase I: Teclistamab and 1.0 mg MezigdomideExperimental treatment 2 interventions

Group C: Expansion CohortExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Number of Participants With Dose Limiting Toxicity Assessed by CTCAE v5.0

Time frame

1 year

Secondary outcomes

Overall response rate

assessed using the International Myeloma Working Group (IMWG) criteria

Time frame

2 years

Locations7

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Sponsors and contacts

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

Memorial Sloan Kettering Cancer Center

Lead sponsor

Bristol-Myers Squibb

Collaborator

Johnson & Johnson