NCT03815279

A Nationwide Phase 2 Trial of Patients With Smoldering and Active Multiple Myeloma (MM)

Iceland Screens Treats or Prevents Multiple Myeloma (iStopMM): A Nationwide Phase 2 Trial of Patients With Smoldering and Active Multiple Myeloma (MM)

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Landspitali University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of treating patients with intermediate risk smoldering multiple myeloma (SMM) with combinational therapy with dexamethasone and lenalidomide (Rd) and patients with high risk SMM with combinational therapy with Rd and carfilzomib.

Detailed description

This is an open label, single center, phase II study assessing the efficacy of treating patients with intermediate-risk smoldering myeloma (SMM) with combinational therapy with dexamethasone and lenalidomide and treating patients with high risk SMM and active multiple myeloma (MM) with combinational therapy with dexamethasone, lenalidomide and carfilzomib. Patients that are eligible for this study are participants in the IstopMM study (ClinicalTrials.gov number, NCT03327597) that are diagnosed with intermediate or high-risk SMM or active MM.

Conditions

• Multiple Myeloma
• Smoldering Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib	Carfilzomib will be administered intravenously three times per cycle (28 day cycles) for cycle 1-12. Thereafter twice per cycle for cycle 13-24
DRUG	Lenalidomide	Lenalidomide PO once daily on days 1-21 of a 28 day cycle
DRUG	Dexamethasone	Dexamethasone will be administered weekly

Timeline

• Start date: 2019-06-24
• Primary completion: 2024-01-01
• Completion: 2028-01-01
• First posted: 2019-01-24
• Last updated: 2019-08-16

Locations

1 site across 1 country: Iceland