A Phase 2 Clinical Trial of Dichloroacetate in Plateau Phase Myeloma - DiCAM

Phase 2

Recruiting

• Conditions: Plasma Cell Myeloma (aka Multiple Myeloma); Cancer - Myeloma

• Registration Number: ACTRN12615000226505
• Lead Sponsor: Department of Haematology - Capital Region Cancer Services- The Canberra Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

*Diagnosis of Plasma Cell Myeloma (at any time) according to WHO criteria
*Aged 18 years or older
*Eastern Co- operative Oncology Group Performance status less than 2
*Life expectancy due to myeloma or co- morbid conditions in the opinion of the treating physician likely to exceed 3 months

AND

*has measurable residual disease i.e.
**Quantifiable serum paraprotein on electrophoresis at least 1g/L OR
**Elevated free kappa (>21mg/L) or lambda light chains (>30mg/L) AND a minimum difference between level of involved/uninvolved light chain of 150mg/L AND an abnormal serum free light chain ratio (normal range = 0.26-1.26)
AND
* is in a ‘Plateau- Phase’ i.e.
** A period of neither progression nor response at least 28 days following the last change in myeloma treatment
**Progression defined as per IWMG

*an increase in the paraprotein by >= 25% and at least 5g/L

*In light chain only patients, >25% increase in difference between involved and uninvolved light chain level, with an absolute increase of >0.1g/L

*development of new lytic lesions

*development of new end organ damage (Renal disease, marrow failure, lytic lesions, hypercalcaemia) attributable to myeloma or new plasmacytomas

**Response defined as reduction in the paraprotein by at least 25% OR in the case of light chain only myeloma, at least 25% decrease in the difference between the involved and uninvolved light chain and an absolute reduction of at least 100mg/L.

* Blood samples to assess for plateau phase must be at least 28 days apart

Exclusion Criteria

*Unable to give informed consent
*Non-secretory myeloma
*Receipt of any active anti-myeloma therapy (excluding bisphosphonates) in the 16 weeks prior to enrolment, with the exception that patients on stable doses of long- term maintenance therapy will be allowed (no dose alteration in the prior 8 weeks).

*Pregnant or breastfeeding
*Unwilling to avoid pregnancy and use birth control (if applicable) during the study and for 4 weeks after completion of the study
*Unable to swallow capsules
*Major surgery within the last 28 days
*Enrolled in another trial or have discontinued from another clinical trial within the last 14 days
*Any serious pre-existing medical condition that, in the opinion of the study doctor would keep you from being on this trial
*Any peripheral motor or sensory neuropathy, neuralgia or paraesthesia (of grade 3 or worse)
*Any pre-existing severe ataxia or tremor (grade 3 or worse)
*Known history of liver disease (cirrhosis established by imaging studies or biopsy) or abnormal liver function tests within the last 14 days (AST or ALT > 3 x ULN or ALP >2.5 x ULN or total bilirubin > 1.5 x ULN)
*Any more than moderate renal impairment i.e. Calculated Creatinine Clearance by Cockcroft Gault formula of greater than or equal to 30 mL/min
*Inadequate cardiac function defined as:
**Electrocardiographic (ECG) evidence of
***Acute ischemia
***Active clinically significant conduction system abnormalities
***>Grade 2 (>480 ms) (QTc) prolongation
***Uncontrolled angina or severe ventricular arrhythmias
***Myocardial infarction within the last 6 months
***Class 3 or higher New York Heart Association Congestive Heart Failure

*Haematological
**Haemoglobin < 80g/L
**Absolute Neutrophil Count (ANC) less than 1.0 x 10^9/L
**Platelet Count less than 50 x 10^9/L
*Any active fungal, bacterial and/or known active viral infection including HIV or hepatitis (A, B, or C).
*A second malignancy which in the opinion of the investigator may affect the interpretation of results

Study & Design

• Study Type: Interventional
• Study Design: Not specified