A 2-stage Phase II study of combination pomalidomide and low dose dexamethasone therapy in patients with relapsed myeloma previously treated wtih lenalidomide maintenance post Autologous Stem Cell Transplant (LEOPARD follow-on study)

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000447550
• Date of registration: 08/05/2015
• Prospective Registration: Yes
• Primary sponsor: Alfred Health
• Public title: A 2-stage Phase II study of combination pomalidomide and low dose dexamethasone therapy in patients with relapsed myeloma previously treated wtih lenalidomide maintenance post Autologous Stem Cell Transplant (LEOPARD follow-on study)
• Scientific title: A 2-stage Phase II study evaluating the safety and efficacy of combination pomalidomide and low dose dexamethasone therapy in patients with relapsed myeloma previously treated wtih lenalidomide maintenance post Autologous Stem Cell Transplant (LEOPARD follow-on study)
• Date of first enrolment: 08/06/2015
• Target sample size: 30
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12615000447550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Ms Nola Kennedy

• Name: Prof Andrew Spencer

Key inclusion & exclusion criteria

Inclusion criteria: 1. 18+ years of age and be able to give informed consent

2. Confirmed diagnosis of multiple myeloma with progressive disease as per IMWG criteria

3. Patients must have evaluable multiple myeloma with, at least of the following:
- serum M-protein greater than or equal to 5g/L, or
- urine M-protein greater than or equal to 200mg/24 hour, or
- serum free light chain (SFLC) >100mg/L (involved light chain) and an abnormal kappa/lambda ratio (>4:1 or <2:1), or
- for IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (total IgA) greater than or equal to 7.5g/L

4. Immediate therapy prior to relapse or progressive disease was lenalidomide maintenance as part of the LEOPARD study
- Note: Patients who discontinued LEOPARD study due to reasons other than progression (such as toxicity, consent withdrawal) and have subsequent relapse may be eligible for inclusion

5. Life expectancy of > 16 weeks

6. Patient must be greater than or equal to 7 days from prior focal radiotherapy, and greater than or equal to 2 weeks from last dose of lenalidomide and/or prednisolone, and/or major surgery prior to the first dose of study drug. No other anti-myeloma therapy is given between cessation of RAP maintenance and commencement of Pomalidomide therapy.

7. Adequate organ function and absence of any other absolute contraindications to the use of pomalidomide or dexamethasone

8. ECOG performance status 0-2

9. All women of childbearing potential must agree to have a negative pregnancy test in the 24hrs before commencing pomalidomide, take adequate precautions to prevent pregnancy, and not plan on conceiving children during or within 6 months following pomalidomide

10. All males must use barrier contraception during and for 4 weeks after completing pomalidomide.

Exclusion criteria: N/A

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Myeloma

myeloma;
myeloma

Intervention(s)

Pomalidomide will commence at a dose of 4mg orally daily from Days 1 to 21 of a 28 day cycle for the duration of the study, until disease progression or relapse
Dexamethasone will commence at a dose of 40mg weekly on Days 1, 8, 15 and 22 of a 28 day cycle for the duration of the study, until disease progression or relapse.

Adherence to protocol will be monitored via regular cycles visits to the trial centre for medical review and safety bloods and drug accountability in the form of drug return.

Primary Outcome(s)

To determine the response rates of salvage treatment with pomalidomide and low dose dexamethasone in patients with MM who develop progressive disease whilst on RAP maintenance post-ASCT.
Response rates to be measured using International Myeloma Working Group IMWG criteria. Assessments include serum protein electrophoresis and immunofixation, urine protein eletrophoresis and immunofixation, serum free light chain assay and Bone Marrow Aspirate Trephine.[at time of maximal response or progression or relapse]

Secondary Outcome(s)

To compare overall response rates (ORR – partial response or better, as defined by the International Myeloma Working Group IMWG criteria) and PFS of study patients to those in comparable cohorts of patients in MM14 study receiving pomalidomide dexamethasone as salvage therapy after multiple lines of prior therapies. [at progression or relapse]

To document progression free survival and overall survival.
[at progression or relapse]

To document the safety and toxicity profile of pomalidomide in patients previously on RAP maintenance.
Possible side effects include haematological toxicites such as neutropenia and thrombocytopenia and non-haemaotogical toxicites such as rash, venous thrombosis/embolism, constipation, hyper or hypo thyroidism, peripheral neuropathy.
Assessed by physical assessment and safety bloods every cycle.[duration of study]

To evaluate kinetics of responses and depth of response (best response, time to response), duration of response. (composite secondary outcome) [at progession or relapse]

Secondary ID(s)

PO-CL-MM-PI-003589

Source(s) of Monetary Support

Clegene Pty Ltd

Secondary Sponsor(s)

Celgene Pty Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Alfred Hospital Ethics Committee