A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination with Elranatamab in Participants with Relapsed and/or Refractory Multiple Myeloma

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Brief summary

The main endpoints include the type, frequency, seriousness, and severity of all aAEs., Establish the RP2D and dosing schedule of mezigdomide in combination with elranatamab.

Detailed description

The secondary endpoints relate to the effectiveness of the treatment. Specific metrics to be examined include the percentage of participants who respond to treatment (overall response rate; ORR), the percentage of participants who have a very good partial response or better, The percentage of participants who have a very good partial response or better (VGPRR) or complete response or better (CRR) as well as additional measures of response including the time to response (TTR; how long it takes for the treatment to start working), duration of response (DOR; how long the response lasts), progression free survival (PFS; how long it takes for the disease to get worse), and overall survival (OS; how long participants stay alive after receiving the treatment, Number of participants who do not have detectable disease in the body with a sensitive laboratory test. This is called minimum residual disease negativity rate.

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Interventions

DRUGCC-92480

DRUGDEXAMETHASONE

DRUGELRANATAMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The main endpoints include the type, frequency, seriousness, and severity of all aAEs., Establish the RP2D and dosing schedule of mezigdomide in combination with elranatamab.	—

Secondary

Measure	Time frame
The secondary endpoints relate to the effectiveness of the treatment. Specific metrics to be examined include the percentage of participants who respond to treatment (overall response rate; ORR), the percentage of participants who have a very good partial response or better, The percentage of participants who have a very good partial response or better (VGPRR) or complete response or better (CRR) as well as additional measures of response including the time to response (TTR; how long it takes for the treatment to start working), duration of response (DOR; how long the response lasts), progression free survival (PFS; how long it takes for the disease to get worse), and overall survival (OS; how long participants stay alive after receiving the treatment, Number of participants who do not have detectable disease in the body with a sensitive laboratory test. This is called minimum residual disease negativity rate.	—

Measure

Time frame

The secondary endpoints relate to the effectiveness of the treatment. Specific metrics to be examined include the percentage of participants who respond to treatment (overall response rate; ORR), the percentage of participants who have a very good partial response or better, The percentage of participants who have a very good partial response or better (VGPRR) or complete response or better (CRR) as well as additional measures of response including the time to response (TTR; how long it takes for the treatment to start working), duration of response (DOR; how long the response lasts), progression free survival (PFS; how long it takes for the disease to get worse), and overall survival (OS; how long participants stay alive after receiving the treatment, Number of participants who do not have detectable disease in the body with a sensitive laboratory test. This is called minimum residual disease negativity rate.

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Countries

Germany, Greece, Norway, Spain

Outcome results

None listed