NCT04009109

Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM

A Phase II Study of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Alliance Foundation Trials, LLC. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized Phase II clinical trial will be conducted to assess the impact on progression free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab. Patients will be randomized to either: Arm A: 12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy. Arm B: 12 cycles of lenalidomide, ixazomib, daratumumab and dexamethasone, followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 years maintenance therapy.

Detailed description

Induction Phase: 28-day treatment cycle. Treatment continues until disease progression or for a maximum of 12 cycles as follows: Cycles 1-2: * Lenalidomide - 15 mg PO QD on Days 1-21 * Ixazomib - 4 mg PO on Days 1, 8, 15 * Daratumumab Subcutaneous - 15mL/1800mg on Days 1, 8, 15, 22 * Dexamethasone - 20 mg PO on Days 1, 2, 8, 9, 15, 16, 22, 23; For participants ≥75, dexamethasone administered on days 1, 8, 15, 22 Cycles 3-6: * Lenalidomide - 15 mg PO QD on Days 1-21 * Ixazomib - 4 mg PO on Days 1, 8, 15 * Daratumumab Subcutaneous - 15mL/1800mg on Days 1, 15 * Dexamethasone - 20 mg PO on Days 1, 2, 8, 9, 15, 16; For participants ≥75, dexamethasone administered on days 1, 8, 15 Cycles 7-12: * Lenalidomide - 15 mg PO QD on Days 1-21 * Ixazomib - 4 mg PO on Days 1, 8, 15 * Daratumumab Subcutaneous - 15mL/1800mg on Day 1 * Dexamethasone - 20 mg PO on Days 1, 2, 8, 9, 15, 16; For participants ≥75, dexamethasone administered on days 1, 8, 15 Maintenance Phase: 28-day treatment cycle. Treatment continues until progression or a maximum of 2 years of maintenance treatment: Arm A • Lenalidomide - 10 mg PO QD on Days 1-21 Arm B * Lenalidomide - 10 mg PO QD on Days 1-21 * Ixazomib - 3 mg (or last tolerated dose from the induction phase) PO on Days 1, 8, and 15 * Daratumumab Subcutaneous - 15mL/1800mg on Day 1 * Dexamethasone - 20mg PO on Day 1; Unless patient is ≥75 then 10mg po day 1 In the maintenance phase, dexamethasone, 20 mg PO orally or IV will be administered to patients as a pre-infusion medication prior to daratumumab dosing. When dexamethasone is reduced to 20 mg/week and is given as pre-infusion medication, patients may receive low-dose methylprednisolone (≤20 mg) orally (or equivalent in accordance with local standards) for the prevention of delayed IRRs as clinically indicated. If the investigator wishes to continue the maintenance regimen at the end of the 2 years maintenance treatment, patients may continue current maintenance as per standard of care.

Conditions

• Myeloma, Multiple

Interventions

Type	Name	Description
DRUG	Lenalidomide	Induction and Maintenance
DRUG	Ixazomib	Induction and Only Maintenance Arm B
DRUG	Daratumumab Injection	Induction and Only Maintenance Arm B
DRUG	Dexamethasone	Induction and Only Maintenance Arm B

Timeline

• Start date: 2020-10-21
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2019-07-05
• Last updated: 2025-12-18

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study