Phase 2 Myeloma Trial, Recruiting NCT05695508 Sponsor: University of Heidelberg Medical Center Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT05695508
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 to 70 years old (inclusive)
  • People who have a general health/activity level score (called an ECOG score) of 0 to 2 at the start of screening, and again just before treatment begins — this scale measures how much a person's illness affects their daily activities
  • People who have been diagnosed with multiple myeloma (a type of blood cancer) that requires treatment, confirmed using standard international diagnostic guidelines
  • People who have a measurable amount of disease in their blood or urine at the time of screening, based on specific protein or light chain levels (confirm with trial site)
  • People joining certain treatment groups (Arms A, A1, B, D, E, E1, F, F1, and G) who are newly diagnosed and for whom high-dose therapy and a stem cell transplant using their own cells is part of the planned treatment (except for groups D and G)
  • People joining treatment groups C or C2 who are newly diagnosed, have completed 4 to 6 cycles of standard combination therapy, have had one stem cell transplant (or two in sequence), have had only one prior line of treatment, and have responded at least partially to that treatment — and whose transplant occurred within 12 months of starting initial treatment and within 6 months of their last transplant at the time of joining the trial (or 7 months if consolidation therapy was also given)

Who may not be able to join:

  • People whose multiple myeloma has spread to the brain or spinal fluid, or who have related neurological symptoms
  • People who have had a stroke or seizure within the 6 months before the trial starts
  • People who have had an organ or tissue transplant that required ongoing immune-suppressing medication
  • People who test positive for HIV, Hepatitis B, or have an active Hepatitis C infection
  • People with a chronic lung condition (COPD) where lung function is below 50% of what is expected for their age and size
  • People with moderate to severe persistent asthma in the past 2 years, or any asthma that is not well controlled, or whose lung function is below 50% of expected
  • People with another medical or mental health condition that could interfere with the trial or that the treating doctor considers a risk to the person's safety
  • People who have a serious allergy, intolerance, or life-threatening sensitivity to any of the medications or ingredients used in the trial
  • People who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 6 months after the last dose of any trial treatment
  • People who plan to father a child while in the trial or within 100 days after the last dose of any trial treatment
  • People joining Arms A, A1, B, D, E, E1, F, F1, or G who have previously had or are currently receiving any treatment for a plasma cell disorder (a category of conditions that includes multiple myeloma), or a stem cell transplant — with the exception of a short emergency course of a corticosteroid medication before treatment
  • People joining Arm B specifically who have nerve pain or nerve damage rated at level 2 or higher on a standard side-effect grading scale
  • People joining Arms A, A1, B, D, E, E1, F, F1 who have taken a strong medication known to affect how the body processes the drug bortezomib within a specific timeframe before enrolling (confirm with trial site for exact timing)
  • People joining Arms C or C2 who had to stop taking the medication lenalidomide because of a side effect from it
  • People joining Arms C or C2 whose multiple myeloma got worse at any point during a prior treatment
  • People joining Arms C or C2 who received a higher-than-allowed amount of a corticosteroid medication in the 14 days before starting trial treatment
  • People joining Arms C or C2 who could not tolerate the standard starting dose of lenalidomide (10 mg)

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 20 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 6221 56

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Heidelberg Medical Center
Registry
ClinicalTrials.gov
Start date
1 December 2022
Est. completion
15 September 2028

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

number of incidence and severity of adverse events [safety and tolerability]

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: 20 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