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

NCT00915408 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-09-02

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and to evaluate the safety of cyclophosphamide when given on days 1 and 8 in a 28 day cycle in doses starting at 300mg ranging to 700mg in combination with Lenalidomide (Revlimid®) plus dexamethasone in patients who present with relapsed or refractory myeloma.

Conditions

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.

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Steve Schey, FRCP FRACP FRCPath · King's College Hospital NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915408 on ClinicalTrials.gov