Randomised Trial in Waldenstrom's Macroglobulinaemia

Conditions

• Waldenstrom's Macroglobulinaemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bortezomib — DRUG
  1.6 mg/m2 subcutaneous bortezomib on days1, 8 and 15 of 28 days cycle
• Cyclophosphamide — DRUG
  Cyclophosphamide:250 mg/sq m, oral, days 1, 8 and 15 of each cycle in the experimental arm. Cyclophosphamide:250 mg/sq m, oral, days 1, 2 and 3 of each cycle in the control arm.
• Rituximab — BIOLOGICAL
  Rituximab: 375 mg/m2 i.v. infusion; days 1, 8, 15 and 22 of cycles 2 and 5 only
• Fludarabine — DRUG
  Fludarabine: 40 mg/sq m, oral, days 1, 2 and 3

Study Details

The purpose of this trial is to assess tolerability and efficacy of the Bortezomib, Cyclophosphamide and Rituximab combination as initial therapy for previously untreated patients with symptomatic Waldenstrom's macroglobulinaemia.

Key Dates

Start date

Jan 31, 2013

Status verified

Jun 2021

Primary completion

Mar 31, 2017

Completion

Aug 2, 2020

Study Design

Enrollment

60 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: bortezomib, cyclophosphamide, rituximab
  Bortezomib:1.6 mg/m2 s.c; days 1, 8, 15 of each cycle. Cyclophosphamide:250 mg/m2 oral; days 1, 8, 15 of each cycle. Rituximab: 375 mg/m2 i.v. infusion; days 1, 8, 15 and 22 of cycles 2 and 5 only. Cycle repeated every 28 days. After 3 cycles of treatment, patients are reassessed and those with evidence of progression stop trial treatment. All other patients continue with further 3 cycles (to a total of 6) unless a clear clinical contradiction to further treatment exist.
• Active Comparator: fludarabine, cyclophosphamide, rituximab
  Fludarabine:40 mg/sq m, oral, days 1,2 and 3 of each cycle. Cyclophosphamide:250 mg/sq m; oral, days 1, 2 and 3 of each cycle. Rituximab: 375 mg/sq m i.v. infusion days 1, 8, 15 and 22 of cycles 2 and 5 only. Cycle repeated every 28 days.After 3 cycles of treatment, patients are reassessed and those with evidence of progression stop trial treatment. All other patients continue with further 3 cycles (to a total of 6) unless a clear clinical contradiction to further treatment exist.

Primary Outcome Measure

Disease response [ Time Frame: 6 months (end of treatment) ]