NCT01450215

Randomized Trial Comparing Lenalidomide With Low Dose Dexamethasone Versus Lenalidomide in Second Line Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is: * A prospective, randomized, open, phase II, multi-centre, interventional study. Patients who are in at least PR and have received lenalidomide as 2nd line treatment for MM will be recruited. * The patients will be randomized into two groups. Group R will receive lenalidomide 25 mg/day p.o. continuously for 21 days and group Rb will receive a similar dose of lenalidomide with the addition of 40 mg of dexamethasone p.o. on days 1, 8, 15 and 22 of every 28 day treatment cycle. Study includes a maximum of 24 cycles including two consolidating cycles per patients.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Revlimid	Group R:25 mg lenalidomide 21 of 28 days will be given orally as maintenance .

Timeline

• Start date: 2011-03-01
• Primary completion: 2016-01-01
• First posted: 2011-10-12
• Last updated: 2016-03-25

Locations

2 sites across 1 country: Sweden