A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Talquetamab — DRUG
  Talquetamab will be administered subcutaneously.
• Daratumumab — DRUG
  Daratumumab will be administered subcutaneously.
• Pomalidomide — DRUG
  Pomalidomide will be administered orally.
• Dexamethasone — DRUG
  Dexamethasone will be administered orally or intravenously.

Study Details

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).

Key Dates

Start date

Oct 13, 2022

Status verified

Jun 2026

Primary completion

Jul 30, 2027

Completion

May 25, 2028

Study Design

Enrollment

864 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)
  Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug Access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled.
• Experimental: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)
  Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled.
• Experimental: Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)
  Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 6 years 6 months ]

Locations (40)

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