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Lenalidomide Maintenance Therapy for Multiple Myeloma

NCT01675141 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-02-05

Study results available
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Summary

Background:

* Multiple myeloma is rarely curable, but it is treatable. Initial treatment is directed at controlling symptoms and reducing the number of myeloma cells. It continues until the cancer stops responding to treatment. At that time, treatment may switch to maintenance therapy, which is given to try to extend the response of the first therapy for as long as possible. Research suggests that lenalidomide maintenance therapy may delay the time for myeloma cells to start to grow and possibly improve survival.
* Lenalidomide is a drug that may reduce or prevent the growth of cancer cells. Researchers want to look at the long-term effect of lenalidomide on immune cells. It will also look at the effects of extended treatment on the cancer and the immune system.

Objectives:

\- To test the long-term effectiveness of lenalidomide therapy for multiple myeloma.

Eligibility:

\- Individuals at least 18 years of age with newly diagnosed or relapsed multiple myeloma.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine sample will be collected. A bone scan and bone marrow biopsy will also be performed.
* Participants will receive lenalidomide maintenance treatment. It will be given according to the standard of care for multiple myeloma. Participants will take lenalidomide every day for 21 days of repeated 28-day cycles.
* Treatment will be monitored with frequent blood tests. Blood tests will look at the effect of the treatment on the immune system.
* Treatment will continue as long as the cancer does not worsen and the side effects are not severe.

Conditions

Interventions

DRUG

Lenalidomide

10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Dickran Kazandijicn, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-20
Primary Completion
2016-05-05
Completion
2017-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01675141 on ClinicalTrials.gov