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

This study is currently recruiting participants.
Verified February 2013 by Indiana University
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT01142232
First received: June 10, 2010
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Lenalidomide plus Melphalan during autologous stem cell transplantation
Drug: Lenalidomide maintenance
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Oral Lenalidomide and High Dose Melphalan Supported by Autologous Peripheral Blood Stem Cell Infusion for Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • To determine the recommended phase II dosing and toxicity profile of lenalidomide when used in combination with high dose melphalan in the setting of autologous stem cell transplantation in patients with multiple myeloma [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the response rate of the regimen [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • To explore the biologic effect of the regimen. [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    The biologic effect of the regimen will be measured using quantitative analysis of tumor load, extent of DNA damage, quantitative analysis of plasma cell by RT-PCR, characterization and quantification of circulating endothelial cells, and using Hevylite assay to correlate with serum monoclonal proteins and serum free kappa and lambda light chain assay.


Estimated Enrollment: 80
Study Start Date: August 2010
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melphalan with lenalidomide
Melphalan will be given on Day -2 and Day -1. Lenalidomide will be given from Day -7 to Day +2.
Drug: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142232

Contacts
Contact: Robin O'Bryant, RN 317-948-6476 obryantr@iupui.edu
Contact: Attaya Suvannasankha, MD 317-274-0843 asuvanna@iupui.edu

Locations
United States, Indiana
IU Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robin O'Bryant, RN    317-948-6476    obryantr@iupui.edu   
Contact: Attaya Suvannasankha, MD    317-274-0843    asuvanna@iupui.edu   
Principal Investigator: Attaya Suvannasankha, MD         
Sponsors and Collaborators
Indiana University School of Medicine
Celgene Corporation
Investigators
Principal Investigator: Attaya Suvannasankha, MD Indiana University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT01142232     History of Changes
Other Study ID Numbers: 1005-06; IUCRO-0290
Study First Received: June 10, 2010
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
autologous stem cell transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Lenalidomide
Thalidomide
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 17, 2014