The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM) (PORYOU)
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ClinicalTrials.gov Identifier: NCT03242460 |
Recruitment Status :
Completed
First Posted : August 8, 2017
Last Update Posted : February 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsed and/or refractorY Multiple Myeloma | Drug: Pomalidomide 4 MG Drug: Dexamethasone 20mg Drug: Cyclophosphamide 400mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | the transplant-ineligible patients with Relapsed and/or refractorY multiple myeloma (MM) who had lenalidomide+dexamethasone (LD) following frontline bortezomib combined chemotherapy |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM) Who Had Lenalidomide Plus Dexamethasone (LD) Following Frontline Bortezomib Combined Chemotherapy, Open-labeled, Multicenter Phase II Study |
Study Start Date : | May 12, 2015 |
Actual Primary Completion Date : | April 24, 2019 |
Actual Study Completion Date : | May 2, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Pomalidomide, Dexamethasone, Cyclophosphamide
Pomalidomide 4mg Days 1-21 Dexamethasone 20mg Days 1, 8, 15, 22 Cyclophosphamide 400mg Days 1, 8, 15
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Drug: Pomalidomide 4 MG
Pomalidomide 4mg Days 1-21
Other Name: pomalyst Drug: Dexamethasone 20mg Dexamethasone 20mg Days 1, 8, 15, 22 Drug: Cyclophosphamide 400mg Cyclophosphamide 400mg Days 1, 8, 15 |
- Median Progression-free Survival (PFS) [ Time Frame: 2 years follow up ]Kaplan-Meier method
- Objective Response Rate (ORR) [ Time Frame: 2 years follow up ]International Myeloma Working Group,( IMWG)
- Overall survival (OS) [ Time Frame: 2 years follow up ]Kaplan-Meier method
- Safety evaluations assessed using Common Terminology Criteria for Adverse Events v4.0 [ Time Frame: 2 years follow up ]Common Terminology Criteria for Adverse Events v4.0

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
- Serum M-protein ≥ 0.5g/dL, or
- In subjects without detectable serum M-protein, Urine M-protein ≥ 200mg/24 hour, or serum free light chai (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
- Patients were ineligible for autologous stem cell transplantation
- Must be relapse refractory to initial therapy with bortezomib, melphalan and prednison and then lenalidomide plus dexamethasone.
- Refractoriness is defined as disease progression on treatment or progression within 6 months after the last dose of a given therapy. Relapse is defined according to the criteria of IMWG
- Males and females ≥ 18 years of age or > country's legal age for adult consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
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Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is >50%)
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
- Calculated creatinine clearance ≥ 30mL/min or creatinine < 3mg/dL.
- Written informed consent in accordance with federal, local and institutional guidelines
Exclusion Criteria:
- Female patients who are lactating or pregnant
- Multiple Myeloma of IgM subtype
- Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained
- POEMS syndrome, plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L, Waldenstrom's Macroglobulinaemia, or Patients with known amyloidosis
- Peripheral neuropathy grade > 2
- Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting pomalidomide treatment
- Focal radiation therapy within 7 days prior to start of pomalidomide. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide
- Immunotherapy (excluding steroids) 21 days prior to start of pomalidomide
- Major surgery (excluding kyphoplasty) within 28 days prior to start of pomalidomide
- Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
- Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
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Second malignancy within the past 3 years except:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Breast carcinoma in situ with full surgical resection
- Patients with steroid or lenalidomide hypersensitivity
- Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to starting pomalidomide treatment
- Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242460
Korea, Republic of | |
Catholic university of korea, Seoul ST. Mary's Hospital. | |
Seoul, Korea, Republic of |
Responsible Party: | Ho Sup Lee, MD, PhD. associate professor, Division of hematology-Oncology, Kosin University Gospel Hospital |
ClinicalTrials.gov Identifier: | NCT03242460 |
Other Study ID Numbers: |
PORYOU |
First Posted: | August 8, 2017 Key Record Dates |
Last Update Posted: | February 20, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | KMMWP |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 Dexamethasone |
Cyclophosphamide Pomalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents |