Multiple MyelomaNCT04234022
Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway in Multiple Myeloma
An observational study of Multiple Myeloma, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Zn-DDC, Lanalidomide with Zn-DDC and Pomalidomide with Zn-DDC
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Oct 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Pregnant patients will not be entered
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
Supratik Basu, supratik.basu@nhs.net
Lucy Stelfox, lucy.stelfox@nhs.net
About this study
Official title: Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway and Improve the Treatment Outcomes of Haematological Malignancies - A Translation Bench Study
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.
Read the detailed 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.
- Conditions
- Multiple Myeloma
- Being tested
- Zn-DDC, Lanalidomide with Zn-DDC, Pomalidomide with Zn-DDC
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zn-DDCDrug
Zn-DDC added to myeloma samples for culturing
Lanalidomide with Zn-DDCDrug
Lanalidomide with Zn-DDC added to myeloma samples for culturing
Pomalidomide with Zn-DDCDrug
Lanalidomide with Zn-DDC added to myeloma samples for culturing
| Study group | Role | What they receive |
|---|---|---|
| Zn-DDC | samples to be exposed with Zn-DDC (Imuthiol) alone Receives: Drug: Zn-DDC | |
| Lenalidomide with Zn-DDC | samples to be exposed with Lenalidomide in combination with Zn-DDC Receives: Drug: Lanalidomide with Zn-DDC | |
| Pomalidomide with Zn-DDC | samples to be exposed with Pomalidomide in combination with Zn-DDC Receives: Drug: Pomalidomide with Zn-DDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imuthiol and zinc efficacy
examine the cyctotoxicity of Imuthiol and zinc in combination with other drugs
Measured: 7 days
Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved
Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start22 Oct 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Wolverhampton
- Responsible party
- Sponsor
- Investigators
- Supratik Basu, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234022
- Sponsor's protocol ID
- 2019HAE109
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2020
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway and Improve the Treatment Outcomes of Haematological Malignancies - A Translation Bench Study
- ClinicalTrials.gov ID
- NCT04234022
- Acronym / sponsor ID
- 2019HAE109
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Collaborators
- University of Wolverhampton
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zn-DDC | – | Drug: Zn-DDCsamples to be exposed with Zn-DDC (Imuthiol) alone |
| Lenalidomide with Zn-DDC | – | Drug: Lanalidomide with Zn-DDCsamples to be exposed with Lenalidomide in combination with Zn-DDC |
| Pomalidomide with Zn-DDC | – | Drug: Pomalidomide with Zn-DDCsamples to be exposed with Pomalidomide in combination with Zn-DDC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant patients will not be entered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zn-DDCZn-DDC added to myeloma samples for culturing | Drug | Zn-DDC |
| Lanalidomide with Zn-DDCLanalidomide with Zn-DDC added to myeloma samples for culturing | Drug | Lenalidomide with Zn-DDC |
| Pomalidomide with Zn-DDCLanalidomide with Zn-DDC added to myeloma samples for culturing | Drug | Pomalidomide with Zn-DDC |
Primary outcome
Imuthiol and zinc efficacy
Time frame: 7 days
examine the cyctotoxicity of Imuthiol and zinc in combination with other drugs
Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved
Time frame: 7 days
Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Supratik Basu principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Supratik Basu (01902307999, supratik.basu@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imuthiol and zinc efficacy (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.