MUK six

Phase 1

Completed

• Conditions: Haematological Oncology; Disease: Myeloma; Cancer; Multiple myeloma

• Registration Number: ISRCTN59395590
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27843120

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-19
• Study Completion: 2014-06-01
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Patients with a previous diagnosis of multiple myeloma based on IMWG 2003 definitions:
1.1. Monoclonal immunoglobulin (M component) on electrophoresis, and on immunofixation of serum or of total 24 hour urine
1.2. Bone marrow (clonal) plasma cells =10% or biopsy proven plasmacytoma
1.3. Related organ or tissue impairment (CRAB symptoms, anemia, hypercalcemia, lytic bone lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections)
2. Relapsed or relapsed-and-refractory myeloma who have received 14 prior lines and now require further treatment
3. Able to give informed consent and willing to follow study protocol
4. Aged 18 years or over
5. ECOG Performance Status = 2
6. Required laboratory values within 14 days of registration:
6.1. Absolute neutrophil count = 1.0 x 109/L. Growth factor support is not permitted within 14 days prior to eligibility assessment
6.2. Platelet count = 100 x 109/L. Platelet support is not permitted within 14 days prior to eligibility assessment
6.3. Haemoglobin = 8.0g/dL. Blood transfusion support is permitted
6.4. Bilirubin = 2 x upper limit of normal (ULN)
6.5. AST and/or ALT = 2.5 x ULN; except in subjects with known hepatic involvement, where AST and/or ALT = 5.0 x ULN
6.6. Serum creatinine = 2.0 x ULN
6.7. Corrected calcium = 2.8 mmol/L
7. Anticipated survival of at least 3 months
8. Evaluable disease per modified IWG criteria, utilising the following assessments as appropriate:
8.1. Serum M protein = 10g/l
8.2. Urine M protein = 200mg/24 hours
8.3. Serum free light chain assay: involved FLC level = 100mg/l. Provided serum FLC ratio is abnormal
9. Female subjects of childbearing potential must have a negative pregnancy test at baseline and agree to use dual methods of contraception for the duration of the study and must continue to do so for 3 months after the end of treatment. Male subjects must agree to use a barrier method of contraception for the duration of the study if sexually active with a female of childbearing potential and must continue to do so for 3 months after the end of treatment.
10. Male or female participants

Exclusion Criteria

1. Pregnant (positive pregnancy test) or breastfeeding women
2. Non-secretory multiple myeloma
3. Previous anti-tumour therapies, including prior experimental agents or approved anti-tumour small molecules and biologics, within 28 days before the start of protocol treatment. Steroid therapy is permitted (maximum 160mg dexamethasone or equivalent), but must be stopped 48 hours prior to study drug administration. Bisphosphonates for bone disease and radiotherapy for palliative intent are also permitted.
4. Concurrent or previous malignancies (<12 months post end of treatment) at other sites with the exception of appropriately treated localised epithelial skin or cervical cancer, or incidental histologic findings of prostate cancer (TMN stage T1a or 1b). Patients with histories (=12 months) of other tumours may be entered
5. Poorly controlled or serious medical or psychiatric illness that, in the Investigator?s opinion, is likely to interfere with participation and/or compliance in this clinical study
6. Patients with significant cardiovascular disease (e.g. history of congestive heart failure requiring therapy, presence of severe valvular heart disease, presence of an atrial or ventricular arrhythmia requiring treatment, uncontrolled hypertension, a history of QTc abnormalities)
7. Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B, or C) hepatitis
8. Gastrointestinal disorders that may interfere with absorption of the study drug
9. Patients who have been refractory to prior bortezomib, i.e. did not achieve at least an MR, or who have progressed on therapy or within 60 days of last dose
10. Participants with peripheral neuropathy CTC grade 2 or higher or grade 1 with pain within 14 days prior to registration
11. Any history of known hypersensitivity to any of the study medication or excipients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicities measured within the first cycle of treatment (21 days)

Secondary Outcome Measures

Name	Time	Method
Response - proportion of participants achieving at least a partial response within 16 cycles of VTD-Pano