NCT04277845

Randomized Phase II Study in Elderly Patients With Newly Diagnosed Multiple Myeloma

Randomized Phase II Study of Bortezomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Elderly Patients With Newly Diagnosed Multiple Myeloma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of bortezomib, lenalidomide and dexamethasone in elderly frail patients with newly diagnosed multiple myeloma.

Detailed description

Group 1: 1 cycle will be repeated every 4 weeks 1. Bortezomib 1.3mg/m2 SC D1, 8, 15 \- Dose adjustment for more than 85 : 1.0mg/m2 SC D1, 8, 15 2. Lenalidomide 25mg/d D1-21 \- Dose adjustment for more than 75 : 15mg/d D1-21 3. Dexamethasone 40mg D1, 8, 15, 22 * Dose adjustment for more than 75 years old: 20mg * If it is difficult to maintain bortezomib due to unacceptable toxicity, it can early discontinue from Group 1. \<for patients with old age or frail\> 1. Bortezomib 1.0mg/m2 SC D1, 8, 15 : Dose adjustment for more than 85 : 1.0mg/m2 SC D1,8,15 2. Lenalidomide 15mg/d D1-21 3. Dexamethasone 20mg D1, 8, 15, 22 Group 2: 1 cycle will be repeated every 4 weeks 1. Lenalidomide 25mg/d D1-21 - Dose adjustment for more than 75: 15mg 2. Dexamethasone 40mg D1, 8, 15, 22 - Dose adjustment for more than 75: 20mg \<for patients with old age or frail\> 1\) Lenalidomide 15mg/d D1-21 2) Dexamethasone 20mg D1, 8, 15, 22

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib, Lenalidomide, Dexamethasone	Bortezomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone

Timeline

• Start date: 2020-08-06
• Primary completion: 2022-03-23
• Completion: 2025-03-01
• First posted: 2020-02-20
• Last updated: 2022-09-09

Locations

1 site across 1 country: South Korea