New drug teclistamab tested for safety in Tough-to-Treat blood cancer
NCT ID NCT07030517
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 5 times
Summary
This study tests the safety of teclistamab, a drug given as a shot, in 75 Indian adults with multiple myeloma that has come back or not responded to at least three prior treatments. The goal is to see how safe it is in routine practice. Participants must have tried specific prior therapies and have worsening disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Teclistamab (a drug given as a shot under the skin)
- What this could lead to
- If successful, this could confirm that teclistamab is a safe option for Indian patients with hard-to-treat multiple myeloma, potentially offering a new treatment choice.
- What could go wrong
- This is a small, early-stage safety study (75 participants) in a specific population, so results may not apply broadly. Side effects are possible, and the drug may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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75 people
The number who actually took part.
- Started
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May 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant with diagnosed RRMM (as per IMWG definitions or investigator's discretion) who have received at least 3 prior lines of therapy including a proteasome inhibitor, an anti-CD 38 antibody and an immunomodulatory agent and have demonstrated disease progression on the last therapy * Documented evidence of progressive disease on last line of therapy based on investigator's determination of response by IMWG response criteria * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and not a woman of child bearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than \[\<\] 1 percent \[%\] per year), preferably with low user dependency, during the treatment period and for a period of 6 months after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during study period * A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study treatment Exclusion Criteria: * Participants who are not eligible to receive teclistamab as per the locally approved prescribing information * Received any prior B cell maturation antigen (BCMA)-directed therapy * Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI, and lumbar cytology are required * Stroke, transient ischemic attack, or seizure within 6 months prior to screening * Participant had major surgery or had significant traumatic injury within 2 weeks prior to enrollment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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All India Institute of Medical Sciences
New Delhi, 110029, India
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Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, 302017, India
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Christian Medical College
Ratnagiri Kilminnal, 632517, India
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Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, 605006, India
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KIMS-Kingsway Hospitals
Nagpur, 440001, India
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M S Ramaiah Medical College and Hospital
Bangalore, 560054, India
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Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, 160012, India
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Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, 110085, India
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Regional Cancer Centre
Thiruvananthapuram, 695011, India
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St. Johns Medical College And Hospital
Bengaluru, 560034, India
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Tata Medical Center
Kolkata, 700156, India
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Tata Memorial Hospital
Mumbai, 400012, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?