Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma

NCT ID: NCT01142232

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-27
• Study Completion Date: 2019-05-18

Brief Summary

This is a research study for newly diagnosed multiple myeloma or multiple myeloma has returned (relapsed). Multiple myeloma is a type of cancer that begins in white blood cells called plasma cells. Plasma cells make proteins that help fight infections. Current therapy for multiple myeloma includes high dose chemotherapy and autologous (patient's own cells) stem cell transplantation.

There will be two parts (or phases) to this study:

The purpose of the first part is to find the highest dose of a drug called lenalidomide (Revlimid®) that can be given in combination with high dose melphalan without causing severe adverse events.

The purpose of the second part is to find out the effects of this treatment (good and bad) on multiple myeloma patients.

Detailed Description

Lenalidomide is a drug that interferes with the development of tiny blood vessels that help tumors grow. Lenalidomide in combination with dexamethasone is approved by the Food and Drug Administration (FDA) for the treatment of relapsed multiple myeloma. It is also approved for the treatment of specific types of myelodysplastic syndrome (MDS), another blood cancer. Other research studies using lenalidomide in combination with other drugs in subjects with newly diagnosed multiple myeloma also show good response rate.

High dose melphalan is approved by the FDA and is commonly used in multiple myeloma treatment prior to stem cell transplantation. This combination of lenalidomide, high-dose melphalan and stem cell transplantation has not been studied in newly diagnosed and relapsed multiple myeloma, so it is considered experimental. In research studies, "experimental" refers to a drug or procedure that has undergone basic laboratory testing and received approval from the US Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered experimental in other diseases or conditions.

In this study, lenalidomide will be given together with melphalan (chemotherapy) with the hope that more disease will be killed before the stem cell transplant. Three months after the transplant, patients will take lenalidomide again with the hope that this will help prolong the time when the disease is in remission.

Conditions

Multiple Myeloma

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Melphalan with lenalidomide

Melphalan will be given on Day -2 and Day -1. Lenalidomide will be given from Day -7 to Day +2.

Group Type: EXPERIMENTAL

Lenalidomide plus Melphalan during autologous stem cell transplantation

Intervention Type: DRUG

Patients will receive a fixed dose of melphalan, while the dose of lenalidomide is escalated according to the protocol defined cohorts. Lenalidomide is given on day -7 to day +2, while intravenous melphalan is given on day -2 and -1. Lenalidomide dosing will be in the morning at approximately the same time each day.

Lenalidomide maintenance

Intervention Type: DRUG

Lenalidomide maintenance therapy will begin on Day +100 to Day +110 provided the protocol-defined criteria are met. The initial starting dose of lenalidomide during maintenance is 10 mg daily on Days 1-28 of each 28-day cycle.

Interventions

Lenalidomide plus Melphalan during autologous stem cell transplantation

Patients will receive a fixed dose of melphalan, while the dose of lenalidomide is escalated according to the protocol defined cohorts. Lenalidomide is given on day -7 to day +2, while intravenous melphalan is given on day -2 and -1. Lenalidomide dosing will be in the morning at approximately the same time each day.

Intervention Type: DRUG

Lenalidomide maintenance

Lenalidomide maintenance therapy will begin on Day +100 to Day +110 provided the protocol-defined criteria are met. The initial starting dose of lenalidomide during maintenance is 10 mg daily on Days 1-28 of each 28-day cycle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Phase I: Patients with diagnosis of multiple myeloma at any stage of disease undergoing high dose chemotherapy and stem cell transplantation.
• Phase II: Patients with myeloma undergoing a first high dose chemotherapy and stem cell transplantation after achieving at least stable disease following induction therapy. Any induction regimen prior to transplantation is allowed. No more than 2 prior lines of therapy prior to transplantation are allowed.
• All previous therapy not associated with peripheral blood stem cell transplant, including radiation, hormonal therapy, and surgery, must have been discontinued 4 weeks prior to treatment in this study.
• ECOG performance status of </= 2 at study entry
• Laboratory test results within protocol-specified ranges
• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®
• Females of childbearing potential must have negative pregnancy test within 24 hours of first prescription for lenalidomide and must commit to either continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control.
• Able to take aspirin daily as prophylactic anticoagulation
• Subject must have the minimum stem cell dose of 5.0 x 10^6 CD34+ cells/kg collected.

Exclusion Criteria

• Pregnant or breast feeding females
• History of intolerance or resistance to lenalidomide
• Known hypersensitivity to thalidomide
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Known seropositive for or active viral infection with human immunodeficiency vrus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis b virus vaccine are eligible.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

Attaya Suvannasankha

OTHER

Sponsor Role: lead

Responsible Party

Attaya Suvannasankha

Assistant Professor of Clinical Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Attaya Suvannasankha, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

IU Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1005-06; IUCRO-0290

Identifier Type: -

Identifier Source: org_study_id