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A Phase I/II, Multi-center, Open Label Study of Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma Relapsed and/or Refractory to Lenalidomide

Phase 1/Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Phase I/II, Multi-center, Open Label Study of Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma Relapsed and/or Refractory to Lenalidomide

This is a prospective multicenter phase I followed by a phase II trial designed to evaluate
the safety and efficacy of the combination of Pomalidomide with Cyclophosphamide and
Prednisone in patients with multiple myeloma relapsed and/or refractory to lenalidomide.

Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment,
treatment and long-term follow-up (LTFU).

The pre-treatment period includes: screening visits, performed at study entry. After
providing written informed consent to participate in the study, patients will be evaluated
for study eligibility. The screening period includes the evaluation of inclusion criteria
described above. Subjects who meet all the inclusion criteria will be enrolled.

The treatment period includes: administration of the salvage treatment PCP for 6 cycles and
maintenance treatment. In order to assess the toxicity of treatment, patients will attend
study centre visits at least every 2 weeks, unless clinically indicated. The response will
be assessed after each cycle.

During the LTFU period, after development of confirmed PD, all patients are to be followed
for survival every 1-3 months via telephone or office visit.

Inclusion Criteria:

- Age ≥ 18 years.

- Patient with multiple myeloma who received 1 to 3 lines of treatment (including
high-dose chemotherapy with stem cell support, conventional poli-chemotherapy,
thalidomide- , bortezomib- and melphalan-based regimens) and is relapsed or relapsed
and refractory (that means relapsed while on salvage or progression within 60 days of
most recent therapy) to lenalidomide therapy.

- Patient has clinical relapse of MM based on standard criteria.

- Patient has measurable disease, defined as follows:

- For secretory multiple myeloma, measurable disease is defined as any
quantifiable serum monoclonal protein value (greater than 1 g/dL of IgG
M-protein, greater than 0.5 g/dL of IgA M-protein or IgD M-protein OR urine
light-chain excretion of more than 200 mg/24 hours)

- For oligo- or non-secretory multiple myeloma, measurable disease is defined by
the presence of measurable soft tissue (not bone) plasmacytomas as determined by
clinical examination or applicable radiographs (i.e., MRI, CT scan).

A measurable lesion is defined as a lesion with minimum largest diameter of >20 mm (if
measured by conventional techniques such as physical exam, conventional CT scan, MRI) or
of >10 mm (if measured by spiral CT scan) in one dimension.

- Patient has a Karnofsky performance status ≥ 60%.

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.

- 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 concomitant standard/experimental anti-myeloma drug or therapy.

- Uncontrolled or severe cardiovascular disease including myocardial infarction within
6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart
failure, uncontrolled angina, clinically significant pericardial disease, or cardiac
amyloidosis Other malignancy within the past 5 years. Exceptions: basal cell or non
metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or FIGO
Stage 1 carcinoma of the cervix.

- Concurrent medical condition or disease (e.g., active systemic infection,
uncontrolled diabetes, pulmonary disease, cardiac disease) that is likely to
interfere with study procedures or results, or that in the opinion of the
investigator would constitute a hazard for participating in this study.

Type of Study:


Study Design:

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

Outcome Measure:

PCP safety and efficacy

Outcome Description:

We aim to identify the maximum tolerated dose (MTD) of Pomalidomide delivered in combination with Cyclophosphamide and Prednisone, defined as the dose that achieves a dose-limiting toxicity (DLT) in 25% of patients. The efficacy will be assessed by evaluating the very good partial response (VGPR) rate following the proposed regimen.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Antonio Palumbo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Hematology - University of Torino - A.O.U. San Giovanni Battista - Torino - Italy


Italy: Ministry of Health

Study ID:




Start Date:

July 2010

Completion Date:

July 2013

Related Keywords:

  • Multiple Myeloma
  • Pomalidomide
  • Relapsed/Refractory to Lenalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell