Phase II study of Bortezomib, Adriamycin and Dexamethasone (PAD) therapy for previously untreated patients with multiple myeloma: Impact of minimal residual disease (MRD) in patients with deferred ASCT

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Myeloma; Cancer; Multiple myeloma

• Registration Number: ISRCTN03381785
• Lead Sponsor: niversity College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-22
• Study Completion: 2015-04-01
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 153

Inclusion Criteria

1. Previously untreated patients with symptomatic myelom
2. Patients suitable for high dose therapy and ASCT
3. = 18 years of age
4. Performance score (PS) of 0-3 (ECO.G). Measurable disease as defined by one of the following:
4.1. Secretory myeloma: Monoclonal protein in the serum or monoclonal light chain in the urine (Bence Jones protein ?200mg/24hours), or serum free light chain (SFLC, involved light chain ?100mg/L provided the FLC ratio is abnormal)
4.2. Non-secretory myeloma: ? 30% plasma cells in the marrow (aspirate and/or biopsy) and at least one plasmacytoma ? 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan)
5. Adequate full blood count within 14 days before registration:
5.1. Platelet count =75x109/L
5.2. Absolute neutrophil count (ANC) =1x109/L
6. Adequate renal function within 14 days before registration:
6.1. Creatinine clearance >30ml/min
7. Adequate hepatobiliary function within 14 days before registration:
7.1. Total bilirubi<2 x upper limit of normal (ULN)
7.2. ALT/AST <2.5 x ULN
8. Adequate pulmonary function:
8.1. No evidence of a history of infiltrative pulmonary disease. If a history, then KCO/DLCO (Carbon Monoxide diffusion in the lung) =50% and/or no requirement for supplementary continuous O2
9. Adequate cardiac function:
9.1. Left ventricular ejection fraction (LVEF) =40% by echocardiogram and ECG.
10. If female and of childbearing potential (WCBP), must have a negative pregnancy test (either serum or urine HCG)
11. Able to give informed consent

Exclusion Criteria

1. Grade 2 peripheral neuropathy or neuropathic pain as defined by NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
2. Pregnant or breast-feeding
3. Unwilling to use adequate contraception during the study and for 6 months after the end of the study treatment womnle of childbearing potential (WCBP) or male whose partner is WCBP
4. Known history of allergy contributable to compounds containing boron or mannitol
5. Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient?s participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-year PFS for patients who, having achieved CR/VGPR following PAD therapy, do not receive any further treatment

Secondary Outcome Measures

Name	Time	Method
ot provided at the time of registration