Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Ms Milena Toncheva
ORCID ID
Contact details
Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
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padimac@ctc.ucl.ac.uk
Additional identifiers
EudraCT number
2010-021598-35
ClinicalTrials.gov number
Protocol/serial number
8726
Study information
Scientific title
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 (PADIMAC)
Acronym
PADIMAC
Study hypothesis
The overall aim of the trial is to provide a reliable estimate of the 2-year progression-free survival (PFS) for patients who receive no further treatment after achieving a major response to induction therapy with PAD (Bortezomib, Adriamycin and Dexamethasone).
Background: Multiple myeloma (MM) is a cancer of white blood cells called plasma cells. The recent incorporation of new agents with significant activity against MM (such as bortezomib) into frontline regimens has resulted in high overall and complete response rates prior to ASCT (autologous stem cell transplant). The substantial activity seen with these new drug combinations prompts an urgent re-examination of the role and timing of ASCT in MM treatment, particularly as recent data indicate that patients who have already achieved a complete response (CR) following induction therapy obtain no further benefit from ASCT. Therefore, the aim of this phase II study is to provide a reliable estimate of the PFS of patients achieving major response post-induction who receive no further treatment.
Ethics approval
10/H0502/58
Study design
Non-randomised interventional trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Myeloma
Intervention
PAD, Patients will receive treatment to maximum response + 1 cycle, with a minimum of 4, and maximum of 6 cycles each of 21 days
Intervention type
Drug
Phase
Phase II
Drug names
Bortezomib, adriamycin, dexamethasone
Primary outcome measure
2-year PFS for patients who, having achieved CR/VGPR following PAD therapy, do not receive any further treatment
Secondary outcome measures
Not provided at the time of registration
Overall trial start date
01/11/2010
Overall trial end date
01/04/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Planned Sample Size: 120
Participant 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 patients participation in this study
Recruitment start date
01/11/2010
Recruitment end date
01/04/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK & UCL Cancer Trials Centre, 90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Institute of Child Health
Endocrinology
London
WC1N 1EH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Leukaemia and Lymphoma Research (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list