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A Phase II Study of Lenalidomide Following Allogeneic Stem Cell Transplant for Multiple Myeloma Patients Who Relapse or Have Disease Progression

Phase 2
18 Years
Open (Enrolling)
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

A Phase II Study of Lenalidomide Following Allogeneic Stem Cell Transplant for Multiple Myeloma Patients Who Relapse or Have Disease Progression


I. To evaluate response of relapsed or progressive multiple myeloma to lenalidomide after
allogeneic stem cell transplant.

II. Proportion of patients achieving a complete, partial or minor response.


I. Evaluate toxicity and tolerability of lenalidomide in this setting.

II. For patients with chronic graft-versus-host disease (GVHD), evaluate the response to

III. Evaluate time to progression (TTP).

IV. Evaluate overall survival (OS).


Patients receive lenalidomide orally (PO) on days 1-21. Courses repeat every 28 days for 2
years or longer in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 3
months thereafter.

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form

- Able to adhere to the study visit schedule and other protocol requirements

- Multiple myeloma, having undergone an allogeneic stem cell transplant from a matched
or mismatched related or unrelated donor and have relapsed or have disease

- Relapse is defined as reappearance of monoclonal protein in serum or urine by
immunofixation, new or increased bone lesions or hypercalcemia

- Disease progression is define as a 25% increase in monoclonal protein in serum or a
50% increase in 24 hour urinary monoclonal protein from the lowest level attained at
any time point after allogeneic transplant or new or increased bone lesions or

- All previous cancer therapy, including radiation, hormonal therapy and surgery, must
have been discontinued at least 4 weeks prior to treatment in this study, excluding
corticosteroids for GVHD

- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at study entry

- Absolute neutrophil count >= 1.5 x 10^9/L

- Platelet count >= 50 x 10^9/L

- Serum creatinine =< 2.0 mg/dL

- Total bilirubin =< 1.5 mg/dL

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2 x
upper limit of normal (ULN) or =< 5 x ULN if hepatic metastases are present

- Females of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 24 hours of
prescribing lenalidomide (prescriptions must be filled within 7 days) and must either
commit to continued abstinence from heterosexual intercourse or begin TWO acceptable
methods of birth control, one highly effective method and one additional effective
method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide

- FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex
condom during sexual contact with a FCBP even if they have had a successful vasectomy

- Disease free of prior malignancies for >= 5 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
or breast

- Able to take aspirin 81 or 325 mg daily as prophylactic anticoagulation (patients
intolerant to acetylsalicylic acid [ASA] may use Coumadin or low molecular weight

- All study participants must be registered into the mandatory RevAssist program, and
be willing and able to comply with the requirements of RevAssist

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form

- Pregnant or breast feeding females; (lactating females must agree not to breast feed
while taking lenalidomide)

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study

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

- Known hypersensitivity to thalidomide

- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs

- Resistance to prior use of lenalidomide

- Concurrent use of other anti-cancer agents or treatments

- Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type
A, B or C

- Acute GVHD grades 3 or 4

Type of Study:


Study Design:

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

Outcome Measure:

Response rate, defined as the proportion of patients achieving complete response (CR), partial response (PR), or minor response (MR)

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

William Bensinger

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium


United States: Institutional Review Board

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Disease Progression



Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109