Phase II Study of Dexamethasone, Thalidomide and Lenalidomide for Subjects With Relapsed or Refractory Multiple Myeloma

Summary

Study Objectives

1. To evaluate the efficacy of the combination of dexamethasone (Decadron®), thalidomide (Thalomid®), and lenalidomide (Revlimid®) as therapy for patients with relapsed or refractory multiple myeloma (MM) who have failed prior treatment with both lenalidomide and thalidomide when used as monotherapies.
2. To evaluate the safety of the combination of lenalidomide, dexamethasone, and thalidomide as a therapy for patients with relapsed or refractory multiple myeloma.

Conditions

• Multiple Myeloma

Interventions

DRUG

dexamethasone

Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy. Maintenance therapy will consist of: • Dexamethasone 20mg weekly days 1, 8, 15, 22 out of a 28 day cycle)

DRUG

thalidomide

Cycles 1-4 • Thalidomide will be given 50mg daily on days 1-7, thereafter 100mg daily on days 8-28 of the first 28-day cycle. Thalidomide will then be given at 100mg/daily for days 1-28 of each subsequent cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy.

DRUG

lenalidomide

Cycles 1-4 • Lenalidomide will be given 25mg daily for days 1-21 of each 28 day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of untoward toxicity. These patients will be then transitioned to maintenance therapy. Maintenance therapy will consist of: • Lenalidomide 25 mg/daily days 1 - 21 out of a 28 day cycle. 15mg/daily on days 1-21 of a 28 day cycle of lenalidomide will be given to patients with a creatinine clearance of \< 40cc/min\*

Sponsors & Collaborators

• Celgene

  collaborator INDUSTRY

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• Ruben Niesvizky, MD · Weill Medical College of Cornell University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-31

Primary Completion

2010-09-22

Completion

2010-09-22

Countries

• United States

Study Locations