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A Phase II Study of Dexamethasone (DECADRON®), Clarithromycin (BIAXIN®), and Pomalidomide (CC-4047®) for Subjects With Relapsed or Refractory Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

A Phase II Study of Dexamethasone (DECADRON®), Clarithromycin (BIAXIN®), and Pomalidomide (CC-4047®) for Subjects With Relapsed or Refractory Multiple Myeloma

This phase II study is a treatment program for patients with relapsed or refractory multiple
myeloma who have had prior treatment with lenalidomide. Up to 54 patients will be enrolled.
Patients who sign informed consent form and fulfill all eligibility criteria will be

ClaPd therapy:

Dexamethasone (40mg ) on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin given orally at
a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.

Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle.

Serial clinic visits and laboratory measurements will be performed to monitor for treatment
response. Those patients who demonstrate progression of disease at any point during ClaPd
therapy will be taken off study.

At the end of every cycle (which may coincide with day 1 of the new cycle), response and
toxicity will be evaluated. During cycle 1, patients will have labwork done weekly (CBC with
differential and blood electrolytes). All patients will remain on study until disease
progression or side effects become excessive. Patients who achieve a stable plateau may be
taken off study if eligible to proceed to high dose chemotherapy and autologous stem cell

Inclusion Criteria:

- Subject must voluntarily sign and understand written informed consent.

- Age > 18 years at the time of signing the consent form.

- Histologically confirmed MM

- Relapsed or refractory myeloma, progression of disease either after prior therapy or
lack of response to currently used therapy.

- Relapsed or progressive disease after at least 3 prior therapeutic treatments or
regimens for multiple myeloma.

- Must have been previously treated with lenalidomide and has been determined to be
refractory, resistant, or relapsed.

- Measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >0.1 g/dL serum
free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable

- Karnofsky performance status ≥70% (>60% if due to bony involvement of myeloma

- Females of childbearing potential (FCBP)† must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to
and again within 24 hours of prescribing lenalidomide and thalidomide (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 4
weeks 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
females of child bearing potential even if they have had a successful vasectomy. See
Appendix V: Pomalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and
Acceptable Birth Control Methods. †A female of childbearing potential is a sexually
mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or
2) has not been naturally postmenopausal for at least 24 consecutive months (i.e.,
has had menses at any time in the preceding 24 consecutive months).

- Able to take aspirin daily as prophylactic anticoagulation (patients intolerant to
ASA may use warfarin or low molecular weight heparin). †

- 1ife expectancy ≥ 3 months

- Subjects must meet the following laboratory parameters:

Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Platelets count ≥ 50,000/mm3
(75 x 109/L) Serum SGOT/AST ≤ 2.0 x upper limits of normal Serum SGPT/ALT <3.0 x upper
limits of normal (ULN) Serum creatinine ≤ 2.5 x upper limits of normal Serum total
bilirubin ≤ 1.5 x upper limits of normal

Exclusion Criteria:

- Patients with non-secretory MM (no measurable monoclonal protein, free light chains,
and/or M-spike in blood or urine).

- Prior history of other malignancies (except for basal cell or squamous cell carcinoma
of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 5

- Myocardial infarction within 6 months prior to enrollment, or NYHA(New York Hospital
Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active
conduction system abnormalities.

- Known HIV infection

- Known hepatitis B or hepatitis C infection.

- Active viral or bacterial infections or any coexisting medical problem that would
significantly increase the risks of this treatment program.

- Any coexisting medical problem or laboratory evaluation that, in the treating
physician's or principal investigator's opinion, makes the patient unsuitable to
participate in this clinical trial.

- Known hypersensitivity to thalidomide or lenalidomide.

- History of thromboembolic event within the past 6 months prior to enrollment.

- 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.

- 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 14 days of baseline.

- Known hypersensitivity to thalidomide or lenalidomide.

- The development of erythema nodorum if characterized by a desquamating rash while
taking thalidomide, CC-4047 or similar drugs.

- Any prior use of CC-4047.

- Concurrent use of other anti-cancer agents or treatments.

Type of Study:


Study Design:

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

Outcome Measure:

response rate

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Ruben Niesvizky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

June 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Weill Cornell Medical CollegeNew York, New York  10021