Phase 2 Myeloma Trial, Recruiting NCT06505369 Sponsor: North Estonia Medical Centre Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT06505369
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:

  • You have been diagnosed with multiple myeloma (MM) confirmed according to recognised international guidelines.
  • You are newly diagnosed with multiple myeloma and your doctors consider you suitable for high-dose chemotherapy and a stem cell transplant.
  • You are generally able to carry out daily activities with little to no limitation (confirm with trial site).
  • If you are HIV-positive, you may still be eligible if your HIV viral load is undetectable, your immune cell count is high enough, you have had no serious HIV-related infections in the past 6 months, and you are on stable HIV treatment.
  • You are willing and able to sign a consent form showing you understand what the study involves.
  • You are able and willing to follow the lifestyle rules set out in the study.
  • If you are a woman who could become pregnant, you have had a negative pregnancy blood test before starting the trial.
  • If you are a woman who could become pregnant, you must either not be sexually active, have a partner who has had a vasectomy, or be using two reliable forms of contraception.
  • If you are a woman, you agree not to donate or freeze eggs for the duration of the study and for 6 months after your last dose of treatment.
  • If you are a man, you agree to use a condom during any sexual activity where ejaculation could occur, throughout the study and for at least 100 days after your last dose of treatment.
  • If you are a man, you agree not to donate sperm during the study and for at least 100 days after your last dose of treatment.
  • Your blood test results meet specific minimum thresholds for red blood cells, platelets, white blood cells, liver function, kidney function, and bilirubin levels (confirm exact values with trial site).

Who may not be able to join:

  • You have a different type of blood or protein disorder such as Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis.
  • There are signs that your multiple myeloma has spread to your brain or spinal fluid.
  • You have moderate or severe nerve pain or nerve damage in your hands or feet.
  • You have another ongoing blood cancer or bone marrow disorder (other than multiple myeloma).
  • You have a history of another cancer that is considered high risk of coming back and may need treatment.
  • You have had another active cancer requiring treatment in the last 24 months, with some exceptions for certain early-stage or cured cancers (confirm with trial site).
  • You have had a stroke in the 6 months before signing the consent form.
  • You have significant heart problems, such as severe heart failure, a recent heart attack or bypass surgery within 6 months, an uncontrolled irregular heartbeat, a history of serious heart rhythm problems, or severe heart muscle disease.
  • You have an uncontrolled medical or mental health condition that could interfere with the study, such as uncontrolled diabetes, an active serious infection, certain autoimmune diseases, a digestive condition that affects how you absorb medicines, severe mental health issues, or substance abuse problems.
  • You have any other condition that, in your doctor's opinion, would make it unsafe or unsuitable for you to take part.
  • You have a known severe allergy or intolerance to any of the medicines used in this trial.
  • You have an active hepatitis B or hepatitis C infection.
  • You have previously received systemic treatment or a stem cell transplant for any plasma cell disorder, except for a short emergency course of steroids.
  • You have had major surgery within 2 weeks before starting treatment, have not fully recovered from surgery, or have major surgery planned during the study period.
  • You have a medical reason why you cannot take the combination of drugs used in this trial (confirm with trial site).
  • You have recently received certain other investigational drugs, live vaccines, certain antibody therapies, or specific medications that affect how drugs are processed in your body (confirm timelines with trial site).
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months of your last dose.
  • You are a man planning to father a child during the study or within 100 days of your last dose.

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 15 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

Principal Investigator: Diana Loigom, MD, North Estonia Medical Centre

Phone: +372 6172173

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
North Estonia Medical Centre
Registry
ClinicalTrials.gov
Start date
19 June 2024
Est. completion
1 November 2026

Where this trial is recruiting

🇩🇰 Denmark 🇪🇪 Estonia 🇳🇴 Norway

Primary endpoints

Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by next generation sequencing ( NGS) after completing consolidation with talquetamab and teclistamab.; Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan after completing consolidation with talquetamab and teclistamab.

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: 15 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