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Evaluation of Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide in Patients With Relapsed and Refractory Myeloma

Phase 1/Phase 2
18 Years
Open (Enrolling)

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Trial Information

Evaluation of Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide in Patients With Relapsed and Refractory Myeloma

There are two parts to this study:

- The first part of this study (Phase 1) will determine a safe dose of the medication
cyclophosphamide in combination with pomalidomide and dexamethasone.

- Once the safest dose has been determined, this study (Phase 2) will look to see the
difference in effectiveness of pomalidomide in combination with high dose dexamethasone
with or without cyclophosphamide for the treatment of patients who have myeloma, which
has relapsed to or become refractory (not responding) to prior treatment.

Inclusion Criteria:

- Patients must have relapsed or refractory multiple myeloma. Refractory disease is
defined as patients who experience disease progression on active therapy or within 60
days after the discontinuation of therapy. Relapsed disease is defined as achievement
of at least a partial response followed by disease progression after 60 days of
discontinuing active therapy.

- Must have measurable disease as assessed by one of the following criteria: Serum
monoclonal protein ≥ 0.5 g/dL by protein electrophoresis; >200 mg of monoclonal
protein in the urine on 24 hour electrophoresis; Serum immunoglobulin free light
chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain

- Must have received at least 2 prior therapies to include prior immunomodulatory drug
(lenalidomide) and the patient must be refractory to lenalidomide (defined as
progressive disease during active therapy or within 60 days of discontinuation of
therapy). All previous cancer chemotherapy (bisphosphonates are not included),
including surgery, must have been discontinued ≥2 weeks prior to first dose of study
drug. Prior radiotherapy must have been completed > 2 weeks prior to the start of
study drug unless the radiation field would not impact marrow reserve in the opinion
of the investigator.

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%

- Must have acceptable organ function: total bilirubin less than 1.5 mg/dL; aspartic
transaminase (AST)/alanine transaminase (ALT) ≤2.5 X institutional upper limit of
normal (ULN); serum creatinine < 3mg/dL

- Patients must have adequate hematologic function as evidenced by the following:

For the Phase I study:

Absolute neutrophil count (ANC) ≥ 1000 per mm³ Platelet count ≥ 50,000 per mm³ For the
Phase II portion, patients with greater than 50% bone marrow plasmacytosis will be allowed
to enter the trial if the platelet count is greater than 30,000 per mm³ and regardless of
baseline absolute neutrophil count if it is felt to be related to active myeloma and if in
the opinion of the investigator, growth factor support can result in improvement in the
neutrophil count to greater than 1000 per mm³ (growth factor can be used during

- Females of childbearing potential (FCBP)† must have a negative serum or urine
pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to
and again within 24 hours of starting pomalidomide 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 pomalidomide. 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 vasectomy.

- Ability to understand and the willingness to sign a written informed consent document

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

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 2 weeks (see Inclusion
Criteria above) or those who have not recovered from adverse events due to agents
administered more than 2 weeks earlier (except for neuropathy).

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

- Any condition, including the presence of laboratory abnormalities, which places the
patient 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 or lenalidomide

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

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

- May not be receiving any other investigational agents

- Pregnant or breast feeding females (Lactating females must agree not to breast feed
while taking pomalidomide).

- Patients with prior pomalidomide therapy (greater than 1 cycle) are excluded.

- Another active malignancy requiring treatment within the next 12 months, with the
exception of basal cell skin cancer, in situ cervical cancer, in situ breast cancer
and asymptomatic prostate cancer

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection (except simple urinary tract or upper respiratory tract infection),
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,
or psychiatric illness/social situations that would limit compliance with study

- Inability to comply with the protocol requirements or participation in any other
clinical study

- Corticosteroid therapies of >20 mg/day prednisone, >4 mg/day dexamethasone, >80
mg/day hydrocortisone, or equivalent

- Allogeneic stem cell/bone marrow transplant within 12 months of first dose of study
drug or active graft versus host disease

- Patients with existing peripheral neuropathy grade >2

Type of Study:


Study Design:

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

Outcome Measure:

Phase I - Maximum Tolerated Dose

Outcome Description:

For the phase I, the primary objective is to determine the maximum tolerated dose of oral weekly cyclophosphamide in combination with pomalidomide and dexamethasone.

Outcome Time Frame:

28 Days

Safety Issue:


Principal Investigator

Rachid Baz, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

December 2013

Related Keywords:

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



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
University of California San Francisco San Francisco, California  941104206
Mount Sinai School of Medicine, The Tisch Cancer Institute New York, New York  10029-6574