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Phase I Study of Lenalidomide to Augment Anti-Tumor Immunity Following Allogeneic Transplantation

Phase 1
18 Years
Open (Enrolling)
Multiple Myeloma, Lymphoma

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Trial Information

Phase I Study of Lenalidomide to Augment Anti-Tumor Immunity Following Allogeneic Transplantation

If you agree to participate in this research study you will be asked to undergo some
screening tests or procedures to find out if you are eligible. Many of these tests and
procedures are likely to be part of regular cancer care and may be done even if it turns out
that you do not take part in the research study. If you have had some of these tests or
procedures recently, they may or may not have to be repeated. These tests and procedures
include: complete medical history, physical examination, blood collection, disease
assessment, bone marrow aspirate, electrocardiogram and HIV/Hepatitis blood test. If these
tests show that you are eligible to participate in the research study, you will begin the
study treatment. If you do not meet the eligibility criteria, you will not be able to
participate in this research study.

Since we are looking for the highest dose of the study drug that can be administered safely
without severe or unmanageable side effects in participants that have lenalidomide, not
everyone who participates in this research study will receive the same dose of the study
drug. The dose you get will depend on the number of participants who have been enrolled in
the study before you and how well they have tolerated their doses. The total duration of the
treatment on this study is 12 weeks or three cycles of 28 days each. At the beginning of
each cycle you will receive all the lenalidomide capsules that you will need to take for
that cycle. If you take more than the prescribed dose of lenalidomide you should seek
emergency medical care if needed and contact study staff immediately. Females of
childbearing potential that may be caring for you should not touch the lenalidomide capsules
or bottles unless they are wearing gloves.

During the treatment you will be seen in the clinic every two weeks. At every visit the
following will be performed: Complete medical history and physical exam, blood collection
and research blood testing. If you have myeloma, at the beginning of each cycle you will
undergo a disease assessment with blood and urine tests. Any unused Revlimid (lenalidomide)
should be returned as instructed through the RevAssist program.

After you have completed taking the drug on the study, the following procedures and tests
will take place: Complete medical history and physical examination, blood collection,
disease assessment, bone marrow aspirate/biopsy and research blood testing. You will be on
the study treatment for about three months and will be followed every three months after
your treatment ends for two years.

Inclusion Criteria:

- Histologically confirmed multiple myeloma or lymphoma and evidence of disease at
least 100 days after an allogeneic stem cell or bone marrow transplantation

- Lymphoma patients must have measurable disease

- No previous cancer therapy within 4 weeks

- Life expectancy of at least 3 months

- Free of prior malignancies for at least 5 years with the exception of currently
treated basal cell, squamous cell carcinoma of the skin or carcinoma in situ of the
cervix or breast

- Must be registered into RevAssist program and willing and able to comply with
RevAssist requirements

- Willing to commit to abstinence or use one highly effective method of birth control
and another effective method of birth control at the same time

Exclusion Criteria:

- Pregnant or breastfeeding

- Any other serious medical condition

- Any condition that places the subject at unacceptable risk if he/she were to
participate in the study

- Use of experimental drug or therapy within 28 days of baseline

- Known significant hypersensitivity to thalidomide or lenalidomide

- Development of erythema nodosum if characterized by desquamating rash while taking
thalidomide or similar drugs

- Chemotherapy or radiotherapy within 4 weeks

- Known seropositive for acute HIV, hepatitis B or C

- Significant concurrent infections

- Non-hematological acute GvHD and/or hematological toxicity of Grade 3 or higher

- Moderate or severe chronic GVHD

Type of Study:


Study Design:

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

Outcome Measure:

Tolerability of lenalidomide

Outcome Description:

To determine the tolerability (with special attention to acute or chronic GVHD) and maximum tolerated dose (out of either 10 or 15 mg daily) of lenalidomide in patients with multiple myeloma or lymphoma who do not achieve a CR or relapse after an allogeneic SCT.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Katarina Luptakova, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Lymphoma
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215