Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway in Multiple Myeloma

The Royal Wolverhampton Hospitals NHS Trust

Status

Enrolling

Conditions

Multiple Myeloma

Treatments

Drug: Lanalidomide with Zn-DDC

Drug: Pomalidomide with Zn-DDC

Drug: Zn-DDC

Study type

Observational

Funder types

Other

Identifiers

NCT04234022

2019HAE109

Details and patient eligibility

About

The outlook for patients with haematological malignancies remains challenging. It has been shown in some early cancer studies that a particular drug called Zn-DDC otherwise known as Imuthiol is highly toxic to cancer stem cells. Imuthiol has been intravenously used in clinical trials with an excellent safety record. Recent novel therapy and immunotherapy in haematological malignancies have improved outcome and survival but come with an increasing cost burden. Imuthiol could be an ideal affordable drug to study on it's own as well as in combination with other drugs in myeloma and other haematological malignancies. This may lead to potential combination therapies which will be very effective as well as affordable in the future. There is the need to look to see if this drug, Imuthiol and along with complementary drugs lenalidomide (Revlimid) and pomalidomide (Pomalyst) can help in haematological malignancy treatment. In order to do this there is the need to see how the cancer cells respond to the drugs in the laboratory before being able to trial the drug (or combination of drugs) out for treatment. The success of this study may lead to quick translation of Imuthiol into haematological malignancy treatment.

Full description

Up to 60 myeloma bone marrow samples from Myeloma patients and 10 bone marrow samples from other haematological malignancy samples (Acute leukaemia's) at Diagnosis and Relapse will be tested.

Patients attending haematology clinics at New Cross Hospital will be reviewed for eligibility of the study by the clinician and if they meet the recruitment criteria, they will be approached to participate at clinic.

After informed consent, participants will be asked to donate an additional 2-3ml sample of bone marrow in a single aliquot for the purpose of this study whilst undergoing a bone marrow aspirate as part of their routine clinical care at diagnosis and relapse.The single aliquot will be sent to the University of Wolverhampton for analysis.

Specific clincial data will be collected at the time of diagnosis and relapse:

Diagnosis
Date diagnosed
Disease stage
Relapse status
Age
Sex
Previous treatments
Date of marrow sample
Marrow trephine
Marrow liquid The clinical data set will remain at The Royal Wolverhampton NHS Trust whilst analysis of the samples takes place. Once the samples have been analysed, the clinical data will then be released to determine relapsed or refractory disease and correlation with the in vitro data.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed with haematological malignancy - either myeloma or acute leukaemia
Patients must be 18 years or over
Patients must be willing and able to give informed consent

Exclusion criteria