The news at a glance
- Teclistamab is an antibody that links the patient's immune cells to myeloma cells so that they kill them [1].
- In about 600 patients whose myeloma had come back after 1 to 3 kinds of treatment, the combination of teclistamab and daratumumab was compared with the usual three-drug treatment [1].
- After 3 years, the disease was under control in about 8 in 10 patients with this combination; with the usual treatment, in only 3 [1].
- This combination was approved in the US in March 2026; serious side effects, especially infections, were a little more common [1].
- Overall survival: how long patients lived.
- Progression-free survival: how long the disease did not get worse.
- Disease-free or event-free survival: how long the disease did not come back after treatment.
- Median: the number that half of patients were above and half below; for example, "a median of 10 months" means that in half of patients the disease stayed under control for at least 10 months.
- Phase 3: a large, careful study comparing a new drug with the usual treatment; the basis of most approvals.
Talk to your doctor about what this result means for you.
What does this finding mean for patients?
If your myeloma has come back after treatment, this new combination is one of the most effective options seen so far when treatments have been compared directly [1]. Because the risk of infection is higher with it, preventing infections and having vaccines are very important; talk to your doctor about whether it is right for you (multiple myeloma).
What was reported?
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Teclistamab first produced a response rate of 63% in the MajesTEC-1 trial in heavily pretreated patients (median of 5 prior lines of therapy) [2]. The question was whether using it earlier, together with daratumumab (an anti-CD38 antibody), could replace the usual triplet regimens [1].
In the phase 3 MajesTEC-3 trial, 587 patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy were randomised to teclistamab + daratumumab (291 patients) or daratumumab + dexamethasone plus pomalidomide or bortezomib (DPd or DVd; 296 patients) [1].
With a median follow-up of 34.5 months, 36-month progression-free survival was 83.4% in the teclistamab + daratumumab group and 29.7% in the control group. Complete response or better was 81.8% vs 32.1% [1]. According to the report presented at ASH 2025, overall survival was also significantly improved, and response rates came close to those previously seen only with CAR-T cell therapy [3]. MajesTEC-3 is the first trial to test a bispecific antibody-based combination in first to third relapse of myeloma [5], and commentators have described it as redefining the limits of what is possible in myeloma treatment [4].
If your multiple myeloma has become active again after your first treatment (or after up to three treatments), this study shows that a combination of two drugs given as injections under the skin, teclistamab and daratumumab, kept the disease under control for a long time in most patients: more than 8 in every 10 patients still had no worsening of their disease after 3 years [1]. This treatment needs careful monitoring, because infections and serious side effects are common with it [1]. Talk to your haematologist about whether this treatment is right for you.
Trial details and regimen (for physicians)
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- The comparator treatment (DPd or DVd) was chosen by the investigator; the primary endpoint was progression-free survival assessed by an independent committee [1].
- Overall response 89.0% vs 75.3% (P<0.001 for all comparisons) [1].
- Serious adverse events 70.7% vs 62.4% and deaths from adverse events 7.1% vs 5.9%; in MajesTEC-1, infections (grade 3 or 4 in 44.8%) and cytokine release syndrome (72.1%; mostly grade 1 to 2) were common [1, 2]. Infection prevention and monitoring are central.
MajesTEC-3 regimen (FDA label)
Teclistamab + subcutaneous daratumumab
Relapsed or refractory myeloma after at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory drug
Relapsed or refractory myeloma after at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory drug
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Day 0 | |||
| Subcutaneous daratumumab-hyaluronidase | 1800 mg / 30,000 units | Subcutaneous over 3 to 5 minutes | One day before teclistamab |
| Step-up dose 1 (day 1) | |||
| Teclistamab | 0.06 mg/kg | Subcutaneous; at least 20 hours after daratumumab | Day 1; 48 hours in hospital |
| Step-up dose 2 (day 3) | |||
| Teclistamab | 0.3 mg/kg | Subcutaneous | 2 to 4 days after dose 1 (up to 7 days if there are adverse events); 48 hours in hospital |
| First treatment dose (day 7) | |||
| Teclistamab | 1.5 mg/kg | Subcutaneous; at least 3 hours after daratumumab | 2 to 4 days after dose 2; daily monitoring for 48 hours near the treatment centre |
| Weeks 2 to 8 | |||
| Teclistamab + daratumumab | 1.5 mg/kg + 1800 mg | Subcutaneous; teclistamab at least 15 minutes after daratumumab | Weekly (at least 5 days apart) |
| Weeks 9 to 24 | |||
| Teclistamab + daratumumab | 3 mg/kg + 1800 mg | Subcutaneous | Every 2 weeks (at least 12 days apart) |
| From week 25 | |||
| Teclistamab + daratumumab | 3 mg/kg + 1800 mg | Subcutaneous | Every 4 weeks (at least 25 days apart) |
Premedication 1 to 3 hours before each step-up dose and the first treatment dose: dexamethasone 16 mg, diphenhydramine 50 mg and paracetamol 650 to 1000 mg. Herpes zoster antiviral prophylaxis and antimicrobial prophylaxis according to guidelines; monitor immunoglobulins and give IVIG or SCIG to keep IgG above 400 mg/dL. Dose reduction of teclistamab is not recommended; CRS, ICANS and infections are managed by withholding and supportive care. After a delay, restart according to the label table (for example, weekly dosing with a gap of 29 to 56 days: from step-up dose 2; more than 56 days: from step-up dose 1). Only through a REMS programme [6].
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Limitations and next steps
- In the US this combination has been approved for myeloma that has come back after earlier treatments.
- In this study patients and doctors knew which treatment was being given, and this combination was not compared with other new treatments such as CAR-T [1].
- Serious side effects, especially infections, were a little more common with it; that is why it is only given in well-equipped centres [1, 2].
- Approval: on 5 March 2026 the FDA approved teclistamab with subcutaneous daratumumab for adults with relapsed or refractory myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory drug (FDA announcement).
- The study was open-label and the control treatment was DPd or DVd; there has been no direct comparison with CAR-T or other bispecific antibodies [1].
- Serious adverse events and deaths from adverse events were slightly more common in the teclistamab group, and this treatment needs centres equipped to manage infections and cytokine release syndrome [1, 2].
The main study
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Key study
1 itemTeclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma
References
6 referencesShow all references, 5 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1
- 2
- 3Advances in multiple myeloma: key updates from the ASH 2025 meeting
- 4MajesTEC-3: Redefining what’s possible in multiple myeloma
- 5Teclistamab plus daratumumab significantly boosts survival for patients with early RRMM
- 6TECVAYLI (teclistamab-cqyv) injection, for subcutaneous use: Prescribing Information
This page is based on reputable scientific sources and was last updated on 28 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
Printed from the website; the full and up-to-date version: https://drdabiri.com/en/news/teclistamab-daratumumab-myeloma/
