Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom's Macroglobulinemia

Conditions

• Waldenstrom's Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ixazomib — DRUG
  Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
• Dexamethasone — DRUG
  Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
• Rituximab — DRUG
  Doses given on Day 1 of induction and maintenance cycles.

Study Details

This research study is evaluating a drug called ixazomib (also known as MLN9708) in combination with dexamethasone and rituximab (the regimen is called IDR) as a possible treatment for Waldenstrom's Macroglobulinemia (WM).

Key Dates

Start date

Apr 30, 2015

Status verified

Aug 2020

Primary completion

Nov 30, 2019

Completion

Nov 30, 2019

Study Design

Enrollment

26 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: IDR
  \- IDR The study treatment will consist on an induction and a maintenance phase. Dose modification will be permitted for toxicity * Induction cycles will be 4 weeks long, Maintenance cycles 8 weeks long. * Ixazomib- administered orally on predetermined days and dosage during Induction and Maintenance Phase * Dexamethasone- administered via IV or orally on predetermined days and dosage during Induction and Maintenance Phase * Rituximab- administered via IV on predetermined days and dosage during Induction and Maintenance Phase

Primary Outcome Measure

Very Good Partial Response Rate (VGPR) for IDR [ Time Frame: 76 weeks ]

Locations (1)

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