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Phase I Study of Bendamustine in Combination With Lenalidomide (CC-5013) and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

Phase 1
18 Years
Open (Enrolling)

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Trial Information

Phase I Study of Bendamustine in Combination With Lenalidomide (CC-5013) and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed symptomatic Multiple
Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that
has been previously treated with at least one cycle of a specific therapy; after
which the patient has shown progressive or refractory disease, and must meet at least
one of the following parameters of measurable disease:

- Bone marrow plasmacytosis with > 10% plasma cells, or sheets of plasma cells, or
biopsy proven plasmacytoma which must be obtained within 6 weeks prior to

- Measurable levels of monoclonal protein (M protein): > 1 g/dL of IgG or IgM M-protein
or > 0.5 g/dL IgA or IgD M protein on serum protein electrophoresis OR > 200 mg of
free light chain on a 24 hour urine protein electrophoresis which must be obtained
within 4 weeks prior to registration OR > 20 mg/dL involved free light chain on serum
free light chain testing with an abnormal kappa:lambda light chain ratio. Note that
if both serum and urine m-components are present, both must be followed in order to
evaluate response. Both SPEP and UPEP must be performed within 28 days prior to

- Patients with lytic bone disease, defined as at least one lytic lesion that can be
accurately measured in at least one dimension.

- Patients must have received prior chemotherapy for their myeloma, but not in the last
4 weeks. Patients may have previously received autologous peripheral blood stem cell
transplantation. Prior treatment with lenalidomide is allowed.

- Patients should not have received any radiation for the preceding 4 weeks before
entry onto the study. Exception: local radiation therapy for symptomatic bone
lesions (eg,uncontrolled pain or high risk of pathologic fracture)

- Age >= 18 years

- Life expectancy of greater than 6 months.

- ECOG performance status >=2 (Karnofsky >=60%). Patients with PS of 3 are eligible if
their PS is due to pain, which would likely improve with treatment.

- Patients must have normal organ and marrow function as defined below, obtained within
4 weeks prior to registration:

- Hgb > 9 g/dL (which may be supported by transfusion or growth factors)

- leukocytes >=2,000/ml

- absolute neutrophil count ≥1000/ ml

- platelets >=75,000/mcL

- total bilirubin >=2.5 mg/dl

- AST(SGOT)/ALT(SGPT) >=5 X institutional upper limit of normal

- creatinine <2.5 mg/dl

- Patients must not be pregnant or breast feeding. Due to the potential teratogenic
properties of lenalidomide, the use of this drug in patients that are pregnant is
absolutely contraindicated. Further, all women of childbearing potential and sexually
active males must agree to avoid conception while participating in this study.
Specifically, women of childbearing potential must either agree to refrain from
sexual intercourse or employ a dual method of contraception, one of which is highly
effective (IUD, birth control pills, tubal ligation or partners vasectomy), and
another additional method (condom, diaphragm, or cervical cap) for 4 weeks prior to
receiving lenalidomide, and for four weeks after discontinuing this therapy. Sexually
active males cannot participate unless they agree to use a condom (even if they have
undergone a prior vasectomy) while having intercourse with a woman of child bearing
potential while taking lenalidomide and for four weeks after stopping treatment.
Women of child bearing potential (those who have not had a hysterectomy or the
absence of menstrual periods for at least 24 consecutive months) must have a negative
pregnancy test 10-14 days prior to the initiation of therapy and a repeat negative
pregnancy test 24 hours prior to the initiation of lenalidomide.

- Ability to understand and the willingness to sign a written informed consent
document. Patient must be informed of the investigational nature of this study.

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering
the study or those who have not recovered from adverse events due to agents
administered more than 4 weeks earlier. Exception: local radiation therapy for
symptomatic bone lesions (eg, uncontrolled pain or high risk of pathologic fracture)

- Patients receiving any other investigational agents.

- Patients with known brain metastases will be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic and other adverse

- Patients with a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to lenalidomide and/or Bendamustine or other agents
used in the study.

- Patients with a second malignancy other than squamous/basal cell carcinoma of the
skin or in situ carcinoma of the cervix unless the tumor was curatively treated at
least two years previously.

- Inability to comply with study and/or follow-up procedures.

- If a patient is on full-dose anticoagulants, the following criteria should be met for

- Must not have active bleeding or pathological conditions that carry high risk of
bleeding (e.g. tumor involving major vessels, known varices).

- Must have a platelet count >75,000.

- Must have stable INR between 2-3.

- Patients who have not collected hematopoietic progenitors and are potential
candidates for autologous transplantation .

- Patients that have a serious cardiac condition, such as myocardial infarction within
6 months or heart disease as defined by the New York Heart Association Class III or

- Patients with prior allogeneic stem cell transplant.

- Non-secretory patients (i.e., patients who do not meet the minimum M-protein or light
chain criteria)

Type of Study:


Study Design:

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

Outcome Measure:

To establish the dose of each drug recommended for a future Phase II protocol with the combination

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Suzanne Lentzsch, M.D., PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh Physicians, Hematology/Oncology


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

January 2013

Related Keywords:

  • Myeloma
  • Relapsed Myeloma
  • Refractory Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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