Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway and Improve the Treatment Outcomes of Haematological Malignancies - A Translation Bench Study

Zn-DDC Drug Trial for Blood Cancers

NCT: NCT04234022 · Status: RECRUITING · Phase: N/A · Sponsor: The Royal Wolverhampton Hospitals NHS Trust · Started: 2021-10-22 · Est. Completion: 2027-12

Plain English Summary

Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway in Multiple Myeloma is a Not Applicable clinical trial sponsored by The Royal Wolverhampton Hospitals NHS Trust studying Multiple Myeloma. This study tests a drug called Zn-DDC (Imuthiol) to see if it can kill cancer stem cells in blood cancers like multiple myeloma. It is for patients diagnosed with multiple myeloma or acute leukemia who are 18 years or older. Participation involves providing cancer cell samples for laboratory testing with Zn-DDC alone or with other drugs like lenalidomide or pomalidomide. Currently, there are no direct alternatives being tested in this specific lab study, but standard treatments for these conditions exist. The trial aims to enroll 70 participants.

Official 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. 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients diagnosed with multiple myeloma or acute leukemia can join. You must be 18 years or older. You must be willing and able to provide informed consent. Pregnant patients cannot participate. This trial is studying Multiple Myeloma, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how well Imuthiol and zinc kill cancer cells in the lab, helping researchers understand the drug's effectiveness and how it works at a cellular level. The specific primary outcome measures are: Imuthiol and zinc efficacy (7 days); Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved (7 days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it explores an affordable drug, Zn-DDC, that may effectively target and kill cancer stem cells in blood cancers, potentially offering a new treatment option. This research targets Multiple Myeloma, where improved treatment options are needed.

Investor Insight

This observational lab study aims to validate a potentially affordable drug for hematological malignancies, a market with significant unmet needs and high treatment costs, suggesting a potential for f

Is This Trial Right for Me?

Ask your doctor if your specific type of blood cancer is suitable for this laboratory study. Participation involves providing a sample of your cancer cells for testing in the lab. You will not be receiving the drug directly as part of this laboratory-based study. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full Eligibility Criteria

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:

* Pregnant patients will not be entered

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04234022?

NCT04234022 is a Not Applicable OBSERVATIONAL study titled "Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway in Multiple Myeloma." It is currently recruiting and is sponsored by The Royal Wolverhampton Hospitals NHS Trust. The trial targets enrollment of 70 participants.

What conditions does NCT04234022 study?

This trial investigates treatments for Multiple Myeloma. The primary condition under study is Multiple Myeloma.

What treatments are being tested in NCT04234022?

The interventions being studied include: Zn-DDC (DRUG), Lanalidomide with Zn-DDC (DRUG), Pomalidomide with Zn-DDC (DRUG). Zn-DDC added to myeloma samples for culturing

What does Not Applicable mean for NCT04234022?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT04234022?

This trial is currently "Recruiting." It started on 2021-10-22. The estimated completion date is 2027-12.

Who is sponsoring NCT04234022?

NCT04234022 is sponsored by The Royal Wolverhampton Hospitals NHS Trust. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04234022?

The trial aims to enroll 70 participants. The trial is currently recruiting and accepting new participants.

How is NCT04234022 designed?

This is a observational study.

What are the primary outcomes being measured in NCT04234022?

The primary outcome measures are: Imuthiol and zinc efficacy (7 days); Cell kill and determination of IC50 (inhibitory concentration) and apoptotic pathways involved (7 days). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04234022 being conducted?

This trial is being conducted at 1 site, including Wolverhampton (United Kingdom).

Where can I find official information about NCT04234022?

The official record for NCT04234022 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04234022. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04234022 testing in simple terms?

This study tests a drug called Zn-DDC (Imuthiol) to see if it can kill cancer stem cells in blood cancers like multiple myeloma. It is for patients diagnosed with multiple myeloma or acute leukemia who are 18 years or older.

Why is this trial significant?

This trial matters because it explores an affordable drug, Zn-DDC, that may effectively target and kill cancer stem cells in blood cancers, potentially offering a new treatment option.

What are the potential risks of participating in NCT04234022?

As this is a laboratory study, direct risks to patients are minimal, as the drug is not administered to people. Potential side effects are assessed through laboratory analysis of cell behavior, not from patient exposure. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04234022?

Ask your doctor if your specific type of blood cancer is suitable for this laboratory study. Participation involves providing a sample of your cancer cells for testing in the lab. You will not be receiving the drug directly as part of this laboratory-based study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04234022 signal from an investment perspective?

This observational lab study aims to validate a potentially affordable drug for hematological malignancies, a market with significant unmet needs and high treatment costs, suggesting a potential for f This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves providing cancer cell samples for laboratory testing with Zn-DDC alone or with other drugs like lenalidomide or pomalidomide. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.