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

Phase 2

Active, not recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Bortezomib, Lenalidomide, Dexamethasone

• Registration Number: NCT04277845
• Lead Sponsor: Samsung Medical Center

Brief 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

Study Timeline

• Study First Submitted: 2020-02-16
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2020-08-06
• Primary Completion: 2022-03-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-09
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Bortezomib, Lenalidomide, Dexamethasone	Group 1: 1 cycle will be repeated every 4 weeks Bortezomib 1.3mg/m2 SC D1, 8, 15 - Dose adjustment for more than 85 : 1.0mg/m2 SC D1, 8, 15 Lenalidomide 25mg/d D1-21 - Dose adjustment for more than 75 : 15mg/d D1-21 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\> Bortezomib 1.0mg/m2 SC D1, 8, 15 : Dose adjustment for more than 85 : 1.0mg/m2 SC D1,8,15 Lenalidomide 15mg/d D1-21 Dexamethasone 20mg D1, 8, 15, 22
Group 2	Bortezomib, Lenalidomide, Dexamethasone	Group 2: 1 cycle will be repeated every 4 weeks Lenalidomide 25mg/d D1-21 * Dose adjustment for more than 75: 15mg 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

Primary Outcome Measures

Name	Time	Method
3-Year Progression-free survival (PFS)	3-years after randomization	The time from randomization into the date of first observation of documented disease progression or death.

Secondary Outcome Measures

Name	Time	Method
Assessment of response	accessed every each cycle (each cycle is 28days)	Response will be determined by the International Myeloma Working Group Response Criteria every cycle

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of