RecruitingPhase 2ACTRN12615000226505

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

In 'plateau phase' myeloma patients does 3 months of oral dichloroacetate lead to a reduction in residual disease burden as assessed by serum paraprotein or light chain levels.


Sponsor

Department of Haematology - Capital Region Cancer Services- The Canberra Hospital

Enrollment

25 participants

Start Date

May 28, 2015

Study Type

Interventional

Conditions

Summary

This study aims to determine whether 3 months of treatment with oral dichloroacetate can supress multiple myeloma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of Plasma Cell Myeloma which 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. Study details: All participants in this study will be treated with a drug called dichloroacetate. This will be taken orally (by mouth) daily for 3 months A number of blood samples will be taken throughout treatment in order to determine how the body responds to treatment. This information will help us determine how well dichloroacetate is tolerated, and whether it has the ability to suppress multiple myeloma.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called dichloroacetate (DCA) can suppress multiple myeloma — a type of blood cancer — when the cancer is in a stable, non-progressing phase called 'plateau phase.' DCA works differently from standard cancer treatments by targeting the way cancer cells produce energy. Participants take DCA capsules by mouth every day for 3 months. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with multiple myeloma (plasma cell myeloma) - Your cancer is currently in 'plateau phase' — it has been neither progressing nor responding to treatment for at least 28 days since your last treatment change - Your cancer shows measurable levels in blood tests - You have a performance status that allows daily activities - Your doctor expects you to live more than 3 months You may NOT be eligible if: - You are unable to give informed consent - Your myeloma produces no measurable protein (non-secretory myeloma) - You have received active anti-myeloma treatment (other than maintenance therapy) within the last 16 weeks - You are pregnant or breastfeeding - You are unable to swallow capsules - You have had major surgery in the last 28 days - You have severe nerve problems (grade 3 or worse neuropathy, tremor, or ataxia) - You have known liver disease or abnormal liver function tests - You have significant kidney impairment - You have significant heart problems Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Oral Dichloroacetate as the sodium salt, administered by mouth for 3 months. Dose will be 25mg/kg twice daily loading for 3 days then reduce to 6.25mg/kg twice daily. A single boost of 25mg/kg on

Oral Dichloroacetate as the sodium salt, administered by mouth for 3 months. Dose will be 25mg/kg twice daily loading for 3 days then reduce to 6.25mg/kg twice daily. A single boost of 25mg/kg on day 8 will occur followed by return to maintenance dose of 6.25mg/kg twice daily. Adherence monitoring will be by capsule count with dispensing of new medication as well as pharmacokinetic monitoring of plasma levels.


Locations(1)

The Canberra Hospital - Garran

ACT, Australia

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ACTRN12615000226505