Condition category
Cancer
Date applied
22/02/2011
Date assigned
22/02/2011
Last edited
26/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
padimac@ctc.ucl.ac.uk

Additional identifiers

EudraCT number

2010-021598-35

ClinicalTrials.gov number

Protocol/serial number

8726

Study information

Scientific title

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 controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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 and dexamethasone

Primary outcome measures

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

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 patient’s 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

http://www.ucl.ac.uk/ich/homepage

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes