Efficacy and Toxicity Study of Pomalidomide and Dexamethasone in Patients Who Have Relapsed After Exposure to Lenalidomide and Bortezomib
Prospective Follow-up of Relapse Myeloma Patients After Previous Exposure to Bortezomib and Lenalidomide Treated on Pomalidomide and Dexamethasone
1 other identifier
interventional
100
1 country
2
Brief Summary
Asian patients with relapsed myeloma after prior treatment with bortezomib and lenalidomide will treatment on pomalidomde and dexamethasone. Baseline, follow-up, survival and toxicity information will be collected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Nov 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 9, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedMay 17, 2018
May 1, 2018
3.3 years
June 5, 2014
May 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the progression free survival (PFS) for pomalidomide and dexamethasone in patients who have relapsed and are refractory to lenalidomide and have previously been treated with bortezomib
2 year
Secondary Outcomes (5)
To assess Overall Response Rate (ORR)
2 year
To see if addition of cyclophosphamide with induce additional response in patient who do not achieve an minimal response (MR) after 3 months
2 year
To assess Overall Survival (OS)
5 year
To assess Duration of Response (DOR)
2 year
To assess Safety and Tolerability
2 year
Study Arms (1)
Pomalidomide and Dexamethasone
EXPERIMENTALPO pomalidomide 4mg from D1-21 and PO dexamethasone 40mg D1, 8, 15 and 22 in a 28-day cycle. PO or IV cyclophosphamide 300mg/m2 on D1, 8 and 15 can be added at the discretion of the treating physician to induce added response under the following circumstances: 1) If there is less than a MR after 3 cycles in the absence of disease progression, or 2) If there is disease progression within the first 3 cycles of Pomalidomide and Dexamethasone treatment. Patients will be assessed every 28 days (+/-10 days). Patients shall receive the treatment until disease progression, unacceptable toxicity as determined by treating physician, withdrawal of consent or mortality (whichever occurs first).
Interventions
Pomalidomide will be given at 4mg once daily for 21 days in a 28-day cycle. Dexamethasone will be given at a dose of 40mg orally once a week for 4 weeks (D1,8,15,22).
Eligibility Criteria
You may not qualify if:
- 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
- Patients with known amyloidosis
- 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)
- Patients with known cirrhosis
- Second malignancy within the past 3 years except:
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National University Hospital, Singaporelead
- Celgenecollaborator
Study Sites (2)
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wee Joo Chng, MBBS
National University Hospital, Singapore
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Consultant
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 9, 2014
Study Start
November 1, 2014
Primary Completion
February 1, 2018
Study Completion
November 1, 2018
Last Updated
May 17, 2018
Record last verified: 2018-05