Efficacy and Toxicity Study of Pomalidomide and Dexamethasone in Patients Who Have Relapsed After Exposure to Lenalidomide and Bortezomib

Phase 2

• Conditions: Multiple Myeloma; Relapse After Use of Lenalidomide and Bortezomib
• Interventions: Drug: Pomalidomide and Dexamethasone

• Registration Number: NCT02158702
• Lead Sponsor: National University Hospital, Singapore

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.

Detailed Description

Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have survival of less than 1 year. Recently, a randomized study of Pomalidomide and dexamethasone conducted in compared with placebo and dexamethasone showed that pomalidomide can improve survival of this group of patients.

Pomalidomide is a new immunomodulatory drug which has been shown to be active in myeloma patients who relapse after bortezomib and lenalidomide. A recent phase III study comparing pomalidomide plus dexamethasone with placebo plus high dose dexamethasone in patients with prior exposure to bortezomib and lenalidomide, showed that the use of pomalidomide significantly improve the overall survival of these patients. However, this study did not include Asian patients. Therefore the efficacy and toxicity of pomalidomide remains to be described in Asian patients

Study Timeline

• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-09
• Study Start: 2014-11
• Primary Completion: 2018-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-13
• Last Update Posted: 2018-05-17
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pomalidomide and Dexamethasone	Pomalidomide and Dexamethasone	PO 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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

National University Hospital; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore