Lenalidomide Maintenance Therapy for Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title: Lenalidomide Maintenance Therapy in Multiple Myeloma: A Phase II Clinical and Biomarker Study

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Background:

Multiple myeloma (MM) remains largely an incurable disease with an estimated median survival of 6-7 years in standard risk myeloma and 2-3 years in high risk disease despite treatment with autologous stem cell transplantation (ASCT).

Maintenance therapy to achieve sustained suppression of residual disease following chemotherapy or ASCT has long been viewed as a desirable approach for extending survival in MM.

Giving the immunomodulatory drug lenalidomide after induction or re-induction treatment may stimulate the immune system in various ways to stop or slow the return of cancer.

It is not yet known how immune stimulatory effects of extended dosing with lenalidomide in the maintenance setting correlate with clinical benefits.

Objectives:

Assess T cell (cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), natural killer T cell (NKT) and normal killer (NK) cell numbers in peripheral blood during the

course of lenalidomide maintenance therapy in treated MM patients.

Eligibility:

Patients with multiple myeloma who have achieved stable disease or better response, assessed at greater than or equal to 4 weeks after completing induction or re-induction treatment

Age greater than or equal to 18 years

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2

Adequate hematological parameters defined by: absolute neutrophil count greater than or equal to 1.0 K/microL, hemoglobin greater than or equal to 8 g/dL, and platelet count greater than or equal to 75 K/microL

Adequate hepatic function, with bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN

Adequate renal function with creatinine clearance (CrCl) of greater than or equal to 40 mL/min. CrCl will be calculated using the Cockcroft-Gault method. If the calculated CrCl based on Cockcroft-Gault method is <40 mL/min, patient will have a 24 hr urine collection to measure CrCl. The measured CrCl must also be greater than or equal to 40 ml/min

Design:

Single arm, single stage, phase II trial of lenalidomide maintenance for treated MM patients who have stable or responsive disease.

After screening, eligibility determination, and enrollment; subjects will receive lenalidomide 10 mg by mouth daily on days 1-21 of repeated 28-day cycles. When necessary, lenalidomide will be held and restarted in accordance with accepted clinical dose modification guidelines.

Subjects may continue lenalidomide until disease progression or unacceptable toxicity or completion of two years of lenalidomide therapy and the 30 day safety follow-up visit.

Blood will be obtained to assess changes in T cell (CD4, CD8), NKT and NK cell numbers by flow-cytometric analysis at pre-specified time points during lenalidomide maintenance.

Blood samples and/or bone marrow samples where possible, will be used for additional research studies, which may include functional analyses of immune-cell subsets, analyses for cytokines, chemokines, antibodies, tumor cell antigen targets, and/or other markers. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

• NCT number: NCT01675141
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Terminated
• Phase: Phase 2
• Start date: August 20, 2012
• Completion date: March 10, 2017