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New treatment option for Multiple Myeloma
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?
Linvoseltamab is an investigational medicine, being studied as a potential treatment for multiple myeloma.
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 main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer. The study is looking at several other research questions, including: Side effects that may be experienced by people receiving linvoseltamab How linvoseltamab works in the body How much linvoseltamab is present in the blood How linvoseltamab may work to treat cancer
- 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. Progression on or after at least 3 prior lines...
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. Patients must...
- Phase 2 (Cohort 3): Patients with MM whose disease meets the following criteria:
- 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.
- Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or \<25% response to therapy. AND, for ALL patients, if they have relapsed after a BCMA-directed CAR-T...
- 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's taking place
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Antwerp, Belgium
- Brussels, Belgium
- Essen, North Rhine-Westphalia, Germany
- Mainz, Rhineland-Palatinate, Germany
- Würzburg, Germany
- Nagoya, Aichi-ken, Japan
- Kashiwa-shi, Chiba, Japan
+ 15 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 - 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?
Study sites include Miami, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States; Louisville, Kentucky, United States; Ann Arbor, Michigan, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.