Condition category
Cancer
Date applied
19/06/2014
Date assigned
19/06/2014
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Elizabeth Ward

ORCID ID

Contact details

Late Phase Haematology Research Team
Cancer & Haematology Centre
Churchill Hospital Old Road
Headington
Oxford
OX3 7LE
United Kingdom
-
Optimal.trial@nhs.net

Additional identifiers

EudraCT number

2012-003947-31

ClinicalTrials.gov number

Protocol/serial number

15878

Study information

Scientific title

A study of Thalidomide, Bendamustine, and Dexamethasone (BTD) vs Bortezomib, Bendamustine, and Dexamethasone (BBD) in patients with renal failure defined as a GFR below 30 ml/min

Acronym

OPTIMAL

Study hypothesis

Renal impairment is a life-threatening complication of myeloma. Up to 20-25% of patients will present at myeloma diagnosis with renal dysfunction.
In this Phase II study, 120 newly diagnosed myeloma patients with eGFR less than 30 ml/min from approximately 20 centres will be randomised to receive either Thalidomide or Bortezomib; all patients will receive bendamustine and dexamethasone in three weekly cycles. All patients will receive a minimum of four cycles.

Aims:
1. Establish whether proteasomal inhibition (bortezomib) or IMiD (thalidomide) based therapy achieves threshold reduction of sFLC in a significant majority of patients
2. Establish whether sFLC response to the first two cycles (early responder) predicts haematological and renal response to the next two cycles of therapy
3. Establish an early time point for assessment of sFLC reduction as a biomarker for response

Ethics approval

13-NE-0361; First MREC approval date 03/03/2014

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

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: Cancer; Subtopic: Haematological Oncology; Disease: Myeloma

Intervention

BTD vs BBD, Thalidomide + Bendamustine + Dexamethasone (BTD) vs Bortezomib + Bendamustine + Dexamethasone (BBD); Follow Up Length: 12 month(s); Study Entry: Single Randomisation only

Intervention type

Drug

Phase

Not Applicable

Drug names

Thalidomide + Bendamustine + Dexamethasone (BTD), Bortezomib + Bendamustine + Dexamethasone (BBD)

Primary outcome measures

Response defined as >50% reduction (from baseline) in sFLC week 6 (end of cycle 2)

Secondary outcome measures

Renal response at end of four cycles of therapy

Overall trial start date

06/06/2014

Overall trial end date

28/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients attending NHS haemato-oncology centres
2. Patients with newly diagnosed symptomatic myeloma and renal failure
3. Patients willing and able to give written informed consent
4. Chronic kidney disease stage 4 or 5
5. GFR <30 ml/min
6. A number of patients with newly diagnosed myeloma and renal failure will have a pre-existing medical condition (hypertension, diabetes etc) causing renal damage. Where there is a medical condition (eg. hypertension, diabetes) which may cause renal damage, there must have been a further decline (=15 ml/min) between previous steady state and the study screening
7. Women of childbearing potential (WCBP) and male participants whose partner is a WCBP must be prepared to use contraception in accordance with (and consent) to the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention Programme
8. WCBP must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention
9. Free of prior malignancies for = 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, localised prostate cancer or carcinoma 'in situ' of the cervix or breast
10. In the Investigator's opinion, is able and willing to comply with all trial requirements
11. Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant exclusion criteria

1. Female patient who is pregnant, lactating or planning pregnancy during the course of the trial or the female partner of a male participant planning a pregnancy during the course of the trial
2. Age <18 years
3. Known allergy to investigational drugs
4. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
5. Any of the following laboratory abnormalities:
5.1. Absolute neutrophil count (ANC) <1.0 x 10(9)/L
5.2. Platelet count <75 x 10(9)/L
5.3. Serum SGOT/AST or SGPT/ALT >3 x upper limit of normal
6. Use of any standard/experimental anti-myeloma drug therapy 14 days prior to trial entry
7. CKD <4
8. Intention to use a physical method of serum free light chain removal such as plasma exchange or high cut-off dialysis
9. Grade 2 neuropathy (NCICTCAE v 4.0) or more will preclude use of thalidomide and bortezomib
10. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Recruitment start date

06/06/2014

Recruitment end date

28/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Late Phase Haematology Research Team
Oxford
OX3 7LE
United Kingdom

Sponsor information

Organisation

Oxford University Hospitals NHS Trust (UK)

Sponsor details

Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.ouh.nhs.uk/

Funders

Funder type

Industry

Funder name

Janssen Cilag International NV

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Napp Pharmaceuticals

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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