A Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple Myeloma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide

Oral lenalidomide 25mg daily on Days 1-21 every 28 days cycles for up to 9 cycles. From Cycle 10 Lenalidomide 25mg orally on days 1-21, every 28 days.

DRUG

Dexamethasone

Dexamethasone 20mgs orally, daily on Days 1-4 and 8-11 repeated every 28 day cycles for up to 9 cycles.

DRUG

Cyclophosphamide

Oral Cyclophosphamide will be added to the regime starting on days 1 and 8. The dose of Cyclophosphamide will be escalated in cohorts rising in 100mg increments from 300 to 700mgs days 1,and 8 every 28 day cycles for up to 9 cycles.

Trial Locations (2)

SE5 9RS

King's College Hospital NHS Foundation Trust, London

SM2 5PT

Royal Marsden NHS Foundation Trust, London

All Listed Sponsors
lead

King's College Hospital NHS Trust

OTHER

NCT00915408 - A Dose Escalation Study of the Combination of Lenalidomide (Revlimid®), Dexamethasone and Cyclophosphamide in Patients Refractory or Relapsing From Stable Disease With Multiple Myeloma | Biotech Hunter | Biotech Hunter