Phase 2 Myeloma Trial, Recruiting NCT04879043 Sponsor: Heidelberg Pharma AG Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT04879043
Recruiting Phase 2

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:

  • People aged 18 or older, of any gender.
  • People with a life expectancy of more than 12 weeks.
  • People whose general health and ability to carry out daily activities falls within a certain range, as measured by a standard cancer performance scale (scores 0 to 2 on the ECOG scale — confirm with trial site if unsure what this means).
  • People who have been diagnosed with active multiple myeloma (MM), confirmed using international diagnostic guidelines.
  • People who have either had a stem cell transplant (SCT) or have been assessed as not suitable for one.
  • People who have previously been treated with at least three specific types of myeloma therapy — an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 treatment — and whose disease is either no longer responding to, or who could not tolerate, current standard treatments.
  • People whose myeloma is measurable according to international myeloma guidelines.
  • People whose heart, liver, kidneys, and other organ systems are functioning at a level defined in the study protocol (confirm specific thresholds with trial site).

Who may not be able to join:

  • People entering the Phase 2a part of the trial who have previously received any treatment — approved or experimental — that targets a protein called BCMA.
  • People whose myeloma has spread to the brain or spinal cord.
  • People with a condition called plasma cell leukemia (a rare and aggressive form of myeloma found in the blood).
  • People with a history of congestive heart failure.
  • People who have had a stem cell transplant (either using their own or a donor's cells) within the 12 weeks before the first treatment, or who are planning to have their own stem cell transplant.
  • People who have had significant complications (graft versus host disease) following a donor stem cell transplant within the 12 months before starting the study treatment.
  • People who have had radiotherapy within 21 days before the first study treatment.
  • People with a history of any other cancer that is known to still be active.
  • People with a known HIV infection.
  • People who have an active infection currently being treated with antibiotics, antivirals, or other anti-infective medicines.
  • People who test positive for hepatitis B surface antigen or hepatitis B core antigen.
  • People who test positive for hepatitis C virus.
  • People with a currently active liver or bile duct disease.

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 27 July 2026
Phase 2: approximately ~30% 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

Phone: + 49 6203 1009 0

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 2
Sponsor
Heidelberg Pharma AG
Registry
ClinicalTrials.gov
Start date
7 February 2022
Est. completion
1 March 2028

Where this trial is recruiting

🇩🇪 Germany 🇭🇺 Hungary 🇵🇱 Poland 🇷🇴 Romania 🇺🇸 United States

Primary endpoints

Number of patients who experience dose-limiting toxicity (DLT) during the first cycle of treatment - Part 1 as defined in Clinical Study Protocol; Objective response rate (ORR)

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: 27 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