Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance

Summary

The purpose of this study is to determine whether this disease will get better if treated with higher doses of Lenalidomide even if the disease returns while taking low doses of Lenalidomide. In patients with multiple myeloma treated with Lenalidomide maintenance, the disease will return. However, the physician currently does not know if the disease would respond to treatment with higher doses of Lenalidomide. This is very important for patients with multiple myeloma because the number of drugs available to treat the disease are limited. It is important to know if Lenalidomide remains still effective and if it can still be used in this situation. This study will try to find out what effects, good and/or bad higher doses of Lenalidomide has on the patient and the disease after it has returned.

Conditions

• Multiple Myeloma

Interventions

DRUG

lenalidomide

patients will begin therapy with lenalidomide 25 mg daily, 21 days out of a 28 day schedule. All patients will be evaluated monthly after every cycle. The dose will be adjusted downward in response to side effects and according to specific guidelines. Symptomatic POD occurring at any time during the study will result in removal of the patient from the study. After 2 cycles of lenalidomide, patients with at least stable disease (SD) will continue lenalidomide indefinitely until asymptomatic POD, at which time dexamethasone will be added at a dose of 40mg weekly. On the other hand, patient with asymptomatic POD after 2 cycles of lenalidomide will have dexamethasone added at a dose of 40 mg weekly. Patients with any type of POD after any cycle that includes dexamethasone will be taken off study. Patients can remain on study on lenalidomide or lenalidomide/dexamethasone indefinitely as long as they do not have POD as stated above and they tolerate the treatment.

Sponsors & Collaborators

• Montefiore Medical Center

  collaborator OTHER

• State University of New York - Downstate Medical Center

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Stamford Hospital

  collaborator OTHER

• Columbia University

  collaborator OTHER

• State University of New York - Upstate Medical University

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Hani Hassoun, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-28

Primary Completion

2021-03-19

Completion

2021-03-19

Countries

• United States

Study Locations