A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)

Conditions

• Waldenström's Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BGB-3111 — DRUG
  160 mg PO BID until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
• Ibrutinib — DRUG
  420 mg PO QD until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor

Study Details

This study evaluated the safety, efficacy and clinical benefit of BGB-3111 (zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.

Key Dates

Start date

Jan 25, 2017

Status verified

Oct 2024

Primary completion

Jun 21, 2022

Completion

Jun 21, 2022

Study Design

Enrollment

201 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A : Ibrutinib
  Participants with the MYD88 mutation received Ibrutinib
• Active Comparator: Arm B: Zanubrutinib
  Participants with the MYD88 mutation received zanubrutinib

Primary Outcome Measure

Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC) [ Time Frame: Up to approximately 2 years and 7 months ]

Locations (7)

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