Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma (MM) Relapsed and/or Refractory to Lenalidomide

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Fondazione Neoplasie Sangue Onlus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Fondazione Neoplasie Sangue Onlus
ClinicalTrials.gov Identifier:
NCT01166113
First received: July 16, 2010
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

This study will evaluate if the combination of Pomalidomide, Cyclophosphamide and Prednisone is safe and provides benefits in patients with multiple myeloma relapsed and/or refractory to lenalidomide.


Condition Intervention Phase
Multiple Myeloma
Drug: Pomalidomide, Cyclophosphamide, Prednisone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Fondazione Neoplasie Sangue Onlus:

Primary Outcome Measures:
  • PCP safety and efficacy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Time-to-progression [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Time to next therapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Tumor response and survival in particular subgroups of patients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pomalidomide, Cyclophosphamide, Prednisone

    Induction

    This multicenter phase I followed by a phase II trial will evaluate the safety and efficacy of the combination Pomalidomide-Cyclophosphamide-Prednisone (PCP) in patients (pts) with MM relapsed/refractory to lenalidomide.

    In the phase I we assess the maximum tolerated dose (MTD) of PCP in 25% of pts. The first 4 pts are given the second dose level, accrual continues with 4 pts per dose level for a maximum of 24 pts.

    The dose level associated with an updated DLT is recommended for the next patient cohort.

    Each patient is assigned to a salvage therapy including Cyclophosphamide and Prednisone (both 50 mg every other d), and Pomalidomide at one of the following doses:1 mg/d;1.5 mg/d;2 mg/d;2.5 mg/d

    In the phase II a total of 43 pts will be treated with the MTD of PCP. Pts enrolled at the MTD during the phase I will be included in the Phase II trial.

    Maintenance (each cycle repeated every 28 d, until PD) Pomalidomide: 2.5 mg/d; Prednisone: 25 mg every other d

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166113

Locations
Italy
A.O.U. San Giovanni Battista
Torino, Italy, 10126
Sponsors and Collaborators
Fondazione Neoplasie Sangue Onlus
Investigators
Principal Investigator: Antonio Palumbo, MD Division of Hematology - University of Torino - A.O.U. San Giovanni Battista - Torino - Italy
  More Information

No publications provided by Fondazione Neoplasie Sangue Onlus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fondazione Neoplasie Sangue Onlus
ClinicalTrials.gov Identifier: NCT01166113     History of Changes
Other Study ID Numbers: PO0023, 2009−014850−13
Study First Received: July 16, 2010
Last Updated: March 21, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Fondazione Neoplasie Sangue Onlus:
Pomalidomide
Relapsed/Refractory to Lenalidomide

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Thalidomide
Lenalidomide
Pomalidomide
Prednisone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 29, 2014