Phase 1 Myeloma Trial, Recruiting NCT04077307 Sponsor: Thomas Helleday Foundation Condition: Myeloma
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Phase 1 Myeloma Trial, Recruiting

NCT04077307
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing and able to give written consent to participate
  • You are between 18 and 75 years old (possibly older if considered healthy enough by the doctors)
  • You have been diagnosed with AML, ALL, DLBCL, Burkitt lymphoma, multiple myeloma, or high-risk MDS (a type of blood cancer or pre-cancer condition), based on specific medical guidelines
  • Your cancer has come back, stopped responding to treatment, or continued to get worse, and there are no suitable standard treatments left available to you
  • For a specific group in the trial (Cohort V): you have relapsed, recurring, or worsening AML or MDS, and you have received no more than 70% of the maximum lifetime dose of a certain type of chemotherapy drug called anthracyclines
  • Doctors estimate you are likely to live for at least 8 more weeks
  • You are well enough to carry out basic daily activities (confirm with trial site for exact fitness level required)
  • Your cancer can be measured through blood tests, bone marrow tests, or scans
  • Your heart is pumping normally, based on your hospital's standard measurements
  • Your liver and kidneys are working well enough, based on specific blood test results (confirm with trial site)
  • Your platelet count meets the minimum required level (this can be supported with a platelet transfusion if needed)
  • You are able to swallow and take medication by mouth
  • If you are a woman who could become pregnant, you have had a negative pregnancy test

Who may not be able to join:

  • You are under 18 years old
  • It has been less than 4 weeks since you last received chemotherapy (some specific lower-dose drugs may have a shorter waiting period — confirm with trial site)
  • It has been less than 1 week since you finished radiotherapy given to manage pain or symptoms
  • It has been less than 2 weeks since you had surgery (minor procedures to allow access, such as inserting a line, may be an exception)
  • You have had a serious heart event such as a heart attack, stroke, unstable chest pain, or heart surgery in the last 6 months
  • You have moderate to severe heart failure
  • You have a history of, or have been found to have, certain abnormal heart rhythms (some types may be acceptable — confirm with trial site)
  • You currently need medication to control heart rhythm, unless it is a stable dose of a beta-blocker or calcium channel blocker
  • Your heart's electrical activity shows a specific abnormality on an ECG (QTc interval over 470ms)
  • You are currently using the painkiller Fentanyl and cannot stop it at least 1 week before starting the trial
  • You are taking antioxidant vitamins or a medication called Acetylcysteine and cannot stop them within 48 hours of starting the trial
  • You are taking certain antidepressant medications and cannot stop them at least 3 weeks before starting the trial (confirm with trial site for specific drugs affected)
  • You have another serious medical condition that could put you at higher risk or affect the trial results
  • You have active cancer spread to the brain (if this was previously known but has been stable for at least 8 weeks, you may still be eligible — confirm with trial site)
  • You have a known active hepatitis B or C infection (stable hepatitis B with antiviral medication may be acceptable — confirm with trial site)
  • You have a known HIV infection
  • You are pregnant or breastfeeding
  • You are able to have children but are not using an effective method of contraception
  • You have taken part in another clinical drug trial recently and not enough time has passed since your last dose (confirm with trial site for exact timeframe)
  • You have a specific type of leukaemia called acute promyelocytic leukaemia (AML M3)
  • You have an ongoing infection that is not under control
  • You are unable to follow the study procedures as required
  • You have significant nerve damage or nerve-related side effects in your hands or feet (grade 2 or higher — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Stefan Deneberg, MD, Karolinska University Hospital

Phone: +46706232505

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Thomas Helleday Foundation
Registry
ClinicalTrials.gov
Start date
3 December 2019
Est. completion
30 December 2026

Where this trial is recruiting

🇩🇰 Denmark 🇷🇸 Serbia 🇸🇪 Sweden

Primary endpoints

Safety of Karonudib (TH1579); Tolerability of Karonudib (TH1579)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov