Phase 2 Myeloma Trial, Recruiting NCT04991103 Sponsor: University of Alabama at Birmingham Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT04991103
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:

  • Adults aged 18 or older who have been newly diagnosed with multiple myeloma and whose doctor has decided they need to start treatment, and who are reasonably physically active (able to carry out light daily activities at minimum).
  • People who have received little or no prior treatment — limited early use of dexamethasone, bortezomib, or cyclophosphamide (for no longer than 4 weeks before joining) to manage urgent symptoms may be acceptable.
  • People whose multiple myeloma shows measurable signs in blood or urine tests, such as a detectable abnormal protein or abnormal light chain levels.
  • People with a life expectancy of at least 12 months.
  • People whose liver and kidney function are within acceptable ranges on blood tests taken within the 3 weeks before starting treatment.
  • Women who could become pregnant must agree to regular pregnancy testing and to use contraception during treatment and for 30 days after the last dose of bortezomib; men must agree to use contraception and not donate sperm during treatment and for 90 days after the last dose of bortezomib.
  • People who agree to enrol in a required safety monitoring programme for the study drug Revlimid (lenalidomide).
  • People whom the treating doctor considers medically suitable to undergo an autologous stem cell transplant (a procedure using the patient's own stem cells).
  • The trial aims for at least 30% of participants to be from ethnic or racial minority groups.

Who may not be able to join:

  • People diagnosed with POEMS syndrome or a blood condition called Waldenstrom's macroglobulinemia.
  • People who have had major surgery, radiation therapy, or an infection requiring treatment within 14 days before starting the trial.
  • People who are pregnant or breastfeeding.
  • People with HIV, hepatitis B, or hepatitis C that is not fully suppressed — those with an undetectable viral load may still be considered eligible (confirm with trial site).
  • People with certain serious heart conditions, including a heart attack within the past 4 months, significant heart failure, severe uncontrolled irregular heartbeat, or specific abnormal heart rhythm findings on an ECG — those with a pacemaker may be considered eligible (confirm with trial site).
  • People who have had a stroke at any point in the past, or a mini-stroke (TIA) within the 12 months before starting treatment.
  • People who have had another type of cancer (not blood-related) within the past 3 years — exceptions may apply for certain low-risk or successfully treated cancers such as some skin cancers, early-stage cervical or breast changes, low-risk prostate cancer, or cancers considered fully cured by surgery (confirm with trial site).
  • People with significant nerve damage or painful nerve problems within the 21 days before joining.
  • People with any other serious medical condition that, in the treating doctor's opinion, could interfere with participation or the ability to provide informed consent.

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

Principal Investigator: Susan Bal, MD, University of Alabama at Birmingham

Phone: 205-934-1908

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
Registry
ClinicalTrials.gov
Start date
22 September 2021
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of patients who are able to attain MRD<10-5 by next generation sequencing after 6 cycles of Dara-VRD and defer AHCT.

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