A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Study population include patients who have initiated the treatment with T-cell redirectors outside of a clinical trial setting.

Trial locations and contacts

68 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 64007957MMY4004: 64007957MMY4004 - REALiTEC

Conditions

Relapsed/Refractory Multiple Myeloma (RRMM)

Being tested

Teclistamab, Talquetamab

Medical subject headings

Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• TeclistamabOther

  Also called TECVAYLI

  No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.

• TalquetamabOther

  Also called TALVEY

  No Intervention will be administered during the study. Retrospective data analysis using participants medical records collected within this study will be entered into CRF.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Describe Baseline Characteristics of Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who Received Teclistamab/ Talquetamab Outside of Clinical Trials

   Participants' demographics and disease characteristics (age, co-morbidities, renal function), and prior antimyeloma therapies will be reported.

   Measured: Baseline (Day 1)

2. Overall Response Rate (ORR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

   ORR is defined as the percentage of patients who have a PR or better as assessed by investigator per International Myeloma Working Group (IMWG) response criteria.

   Measured: Up to 40 months

3. Time to First Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

   Time to first response is defined as the time between date of first dose of teclistamab/talquetamab and the date when patient has achieved first response, as assessed by investigator per IMWG response criteria.

   Measured: Up to 40 months

4. Time to Best Response in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

   Time to best response is defined as the time between date of first dose of teclistamab/talquetamab and the date of the best response, as assessed by investigator per IMWG response criteria.

   Measured: Up to 40 months

5. Duration of Response (DOR) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

   DOR will be calculated among participants (with a PR or better response) from the date of the first response (PR or better) to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria.

   Measured: Up to 40 months

6. Minimal Residue Assessment (MRD) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

   Number of participants with MRD negative rate will be assessed.

   Measured: Up to 40 months

7. Overall Survival (OS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

   OS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of the participant's death.

   Measured: From the date of first dose of teclistamab/talquetamab to the date of the participant's death (up to 40 months)

8. Progression Free Survival (PFS) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

   PFS is defined as the time from the date of first dose of teclistamab/talquetamab to the date of first evidence of progressive disease, as assessed by investigator per IMWG response criteria, or death due to any cause, whichever occurs first.

   Measured: Up to 40 months

9. Time to Next Treatment (TTNT) in Participants with RRMM who Received Teclistamab/Talquetamab Outside of Clinical Trials

   TTNT is defined as the time from the date of first dose of teclistamab/talquetamab to the start of the next line of antimyeloma treatment.

   Measured: Up to 40 months

10. Describe the Safety Management of Teclistamab/Talquetamab in the Treatment of Participants with RRMM Outside of Clinical Trials

    Incidence and severity of adverse events (AEs) including immune effector cell-associated neurotoxicity syndrome (ICANS), cytokine release syndrome (CRS) and other AEs as well as medications used for prophylaxis and management of adverse events will be reported.

    Measured: Baseline (Day 1) up to end of treatment (up to 40 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Feb 2024
2. Study start18 Dec 2023
3. Primary completion30 Aug 2026 (estimated)
4. Study completion24 Sep 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Relapsed/Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.