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Trial record 1 of 794 for:    LENALIDOMIDE AND cells
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Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01142232
Recruitment Status : Active, not recruiting
First Posted : June 11, 2010
Last Update Posted : August 20, 2018
Information provided by (Responsible Party):
Attaya Suvannasankha, Indiana University

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : August 27, 2010
Actual Primary Completion Date : August 31, 2015
Estimated Study Completion Date : December 1, 2018

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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: Day 100 ]

Secondary Outcome Measures :
  1. To evaluate the response rate of the regimen [ Time Frame: Day 100 ]
  2. To explore the biologic effect of the regimen. [ Time Frame: Day 100 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01142232

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United States, Indiana
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Attaya Suvannasankha
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Principal Investigator: Attaya Suvannasankha, MD Indiana University School of Medicine

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Responsible Party: Attaya Suvannasankha, Assistant Professor of Clinical Medicine, Indiana University Identifier: NCT01142232     History of Changes
Other Study ID Numbers: 1005-06; IUCRO-0290
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Attaya Suvannasankha, Indiana University:
autologous stem cell transplantation
Additional relevant MeSH terms:
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Neoplasms, Plasma Cell
Multiple Myeloma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents