Clinical trial · Interventional
Pomalidomide, Cyclophosphamide and Prednisone (PCP) in Patients With Multiple Myeloma (MM) Relapsed and/or Refractory to Lenalidomide
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
NCT01166113CI-TRIAL-00067673PCPcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pomalidomide, Cyclophosphamide, Prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PCP
- interventionNames
- Drug: Pomalidomide, Cyclophosphamide, Prednisone
Primary outcomes (1)
- measure
- PCP safety and efficacy
- timeFrame
- 3 years
- 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.
Secondary outcomes (5)
- measure
- Overall survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLarocca A, Montefusco V, Bringhen S, Rossi D, Crippa C, Mina R, Galli M, Marcatti M, La Verde G, Giuliani N, Magarotto V, Guglielmelli T, Rota-Scalabrini D, Omede P, Santagostino A, Baldi I, Carella AM, Boccadoro M, Corradini P, Palumbo A. Pomalidomide, cyclophosphamide, and prednisone for relapsed/refractory multiple myeloma: a multicenter phase 1/2 open-label study. Blood. 2013 Oct 17;122(16):2799-806. doi: 10.1182/blood-2013-03-488676. Epub 2013 Aug 16. PMID 23954889