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Report for Clinical Trial NCT02400437

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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).

NCT02400437 Waldenstrom's Macroglobulinemia
MeSH:Waldenstrom Macroglobulinemia
HPO:Monoclonal immunoglobulin M proteinemia

3 Interventions

Name: Ixazomib

Description: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Type: Drug
Group Labels: 1

IDR

Name: Dexamethasone

Description: Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
Type: Drug
Group Labels: 1

IDR

Name: Rituximab

Description: Doses given on Day 1 of induction and maintenance cycles.
Type: Drug
Group Labels: 1

IDR


Primary Outcomes

Description: Rate of very good partial response or better in patients treated with IDR

Measure: Very good partial response rate (VGPR) for IDR

Time: 76 weeks

Secondary Outcomes

Description: Overall response including the rate of complete response (CR), partial response (PR), minimal response (MR), stable disease (SD) and progressive disease (PD)

Measure: Overall response rate

Time: 2 Years

Measure: Progression-free survival (PFS)

Time: 4 years

Description: To evaluate the attainment of response, and depth of response and expression of MYD88 L265P and CXCR4-WHIM mutations in WM

Measure: Response rate by MYD88 L265P and CXCR4-WHIM status

Time: 2 Years

Measure: Disease free survival (DFS)

Time: 4 Years

Measure: Time to progression (TTP)

Time: 4 Years

Measure: Duration of Response (DOR)

Time: 4 Years

Measure: Time to Next Therapy (TTNT)

Time: 4 Years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L265P

Response rate by MYD88 L265P and CXCR4-WHIM status. --- L265P ---

To evaluate the attainment of response, and depth of response and expression of MYD88 L265P and CXCR4-WHIM mutations in WM. --- L265P ---



HPO Nodes


HPO: