Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Teclistamab — DRUG
  Teclistamab will be administered via a subcutaneous injection (SC)
• Lenalidomide — DRUG
  Lenalidomide will be administered orally

Study Details

This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.

Key Dates

Start date

Sep 8, 2022

Status verified

Jun 2026

Primary completion

Apr 30, 2028

Completion

Apr 30, 2032

Study Design

Enrollment

1,594 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Teclistamab-Lenalidomide (Tec-Len)
  Teclistamab will be administered via a subcutaneous injection (SC)
• Active Comparator: Arm B Lenalidomide Alone (Len)
  Lenalidomide orally.
• Experimental: Arm C Teclistamab-Alone (Tec)
  Teclistamab will be administered via a subcutaneous injection (SC)

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: from randomization to the date of disease progression or death (approximately up to 8 years) ]

Central Contacts

• Christine Witty
  +31 10 268 70 65
  [email protected]
• Sabrin Tahri
  +31 10 268 70 65
  [email protected]

Locations (42)

Find similar trials in Phoenix, AZ

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