Multiple Myeloma study: Linvoseltamab
Official title Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT03761108
What this study is testing
What is Linvoseltamab?
This is an investigational medicine being studied as a potential treatment for multiple myeloma. It is designed to help the body's immune system recognize and attack cancer cells.
Also referred to as REGN5458, Lynozyfic.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how safe linvoseltamab is, find the best dose, and look for early signs it might treat the cancer.
- Who it's for
- Adults who have multiple myeloma that has come back or did not respond to previous treatments.
- What's involved
- Participants will receive linvoseltamab at different dose levels and have blood tests and other checks to monitor safety and drug levels.
- Time commitment
- The trial runs through Phase 1/2 with multiple visits over several months to give the drug and perform follow‑up assessments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria
- Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol.
- Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical...
- Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria: a.
You likely can't join if
- 1\. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström...
- 5\. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study...
- Note: Other protocol defined inclusion / exclusion criteria apply
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria
- Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol.
- Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or...
- Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b.
- Phase 2 (Cohorts 1 and 2): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b.
- Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR
- Patients must be triple- refractory, defined as being refractory\ to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody.
- Treatment with a CAR-T must have been associated with a response of PR or better, and
- If CAR-T cellular therapy was the most recent prior therapy, excluding corticosteroids, then treatment must have been a minimum of 60 days prior to treatment with linvoseltamab. Key
- 1\. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy...
- 5\. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment
- Note: Other protocol defined inclusion / exclusion criteria apply
The study team makes the final eligibility decision.
Where it is enrolling
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Seattle, Washington, United States
- Antwerp, Belgium
- Nagoya, Aichi-ken, Japan
- Kashiwa-shi, Chiba, Japan
- Maebashi, Gunma, Japan
- Kasama-shi, Ibaraki, Japan
- Kyoto, Kyoto, Japan
- Tokushima, Tokushima, Japan
- Tokyo, Japan
- Goyang, South Korea
- Seoul, South Korea
- Barcelona, Catalonia, Spain
- Pamplona, Navarre, Spain
- Madrid, Salamanca, Spain
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tampa, Florida, United States; Atlanta, Georgia, United States; Louisville, Kentucky, United States; New York, New York, United States; Columbus, Ohio, United States; Portland, Oregon, United States and 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.