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Phase I/II Study of Oral Lenalidomide and High Dose Melphalan Supported by Autologous Peripheral Blood Stem Cell Infusion for Patients With Multiple Myeloma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Phase I/II Study of Oral Lenalidomide and High Dose Melphalan Supported by Autologous Peripheral Blood Stem Cell Infusion for Patients With Multiple Myeloma

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.

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
- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

48 months

Safety Issue:


Principal Investigator

Attaya Suvannasankha, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine


United States: Institutional Review Board

Study ID:

1005-06; IUCRO-0290



Start Date:

August 2010

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • autologous stem cell transplantation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



IU Simon Cancer CenterIndianapolis, Indiana  46202