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

NCT ID: NCT02158702

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-11-30

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

Conditions

Multiple Myeloma; Relapse After Use of Lenalidomide and Bortezomib

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Pomalidomide and Dexamethasone

Intervention Type: DRUG

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).

Interventions

Pomalidomide and Dexamethasone

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).

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

1. Female patients who are lactating or pregnant

2. Multiple Myeloma of IgM subtype

3. Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained

4. POEMS syndrome

5. Plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L

6. Waldenstrom's Macroglobulinaemia

7. Patients with known amyloidosis

8. Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting pomalidomide treatment

9. 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

10. Immunotherapy (excluding steroids) 21 days prior to start of pomalidomide

11. Major surgery (excluding kyphoplasty) within 28 days prior to start of pomalidomide

12. 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

13. 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)

14. Patients with known cirrhosis

15. Second malignancy within the past 3 years except:

1. Adequately treated basal cell or squamous cell skin cancer

2. Carcinoma in situ of the cervix

3. Breast carcinoma in situ with full surgical resection

16. Patients with myelodysplastic syndrome

17. Patients with steroid or lenalidomide hypersensitivity

18. Prior treatment with pomalidomide

19. Ongoing graft-versus-host disease

20. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to starting pomalidomide treatment

21. Contraindication to any of the required concomitant drugs or supportive treatments

22. 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Haematology-Oncology

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wee Joo Chng, MBBS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

National University Hospital

Singapore, , Singapore

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2014/00498

Identifier Type: -

Identifier Source: org_study_id