BridgeMD
New treatment option for Multiple Myeloma
Official title IMMUNOPLANT for Newly Diagnosed Multiple Myeloma
ClinicalTrials.gov ID: NCT06376526
What this study is testing
What is Linvoseltamab?
Linvoseltamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
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 purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition.
- 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
- Diagnosis of newly-diagnosed multiple myeloma (NDMM) per International Myeloma Working Group (IMWG) criteria documented initially prior to induction...
- Documentation of having received a triplet or quadruplet based initial combination therapy containing at least two of the following: Immunomodulatory...
- Documentation of attaining a best response of very good partial response (VGPR) or better but MRD+ (sensitivity: ≤10\^-5) after at least 4 cycles of...
- Age ≥18 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg, pain) may be...
You likely can't join if
- Patients who have received prior systemic therapies for MM other than initial IMiD/PI/anti-CD38-based combination therapy (receiving limited cycles...
- Patients who are receiving any other investigational agents for any reasons.
- Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration.
- Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial...
- Patient has any of the following:
- Human immunodeficiency virus (HIV)-positive with 1 or more of the following:
See the full eligibility criteria
Who can join
- Diagnosis of newly-diagnosed multiple myeloma (NDMM) per International Myeloma Working Group (IMWG) criteria documented initially prior to induction treatment.
- Documentation of having received a triplet or quadruplet based initial combination therapy containing at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and/or anti-cluster of...
- Documentation of attaining a best response of very good partial response (VGPR) or better but MRD+ (sensitivity: ≤10\^-5) after at least 4 cycles of combination therapy. Note: Patients who at baseline prior to initial...
- Age ≥18 years.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg, pain) may be allowed after discussion with the PI (APPENDIX A).
- Adequate organ function, which is defined as follows:
- a. Absolute neutrophil count (ANC) ≥1,000 cells/microliter (mcL) (unless patient has ethnic/cyclic neutropenia or if neutropenia is thought to be due to MM)
- b. Platelets ≥50,000 platelets/mcL
- c. Hemoglobin ≥8 g/dL (transfusions permitted)
- d. Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) or direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of \<3...
- e. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) ≤ 2.5 X ULN
- f. Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 (note that measured glomerular filtration rate [GFR], ie, 24-hour urine, can also be used)...
- g. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of...
- h. Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. For more...
- Willing and able to comply with clinic visits and study-related procedures.
What rules you out
- Patients who have received prior systemic therapies for MM other than initial IMiD/PI/anti-CD38-based combination therapy (receiving limited cycles of other induction therapies, eg, cyclophosphamide, bortezomib and...
- Patients who are receiving any other investigational agents for any reasons.
- Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration.
- Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial, anticoagulation, tumor lysis, or hydration prophylaxis given prior to therapy...
- Patient has any of the following:
- Human immunodeficiency virus (HIV)-positive with 1 or more of the following:
- i. History of acquired immune deficiency syndrome (AIDS)-defining conditions cluster of differentiation 4 (CD4) count \<350 cells/mm3
- ii. Detectable viral load during screening or within 6 months prior to screening
- iii. Not receiving highly active anti-retroviral therapy
- iv. Had a change in anti-retroviral therapy within 6 months of the start of screening
- v. Receiving anti-retroviral therapy that may interfere with study treatment as assessed after discussion with the Sponsor-Investigator in consultation with study pharmacist
- Hepatitis B infection (ie, hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV)-deoxyribonucleic acid [DNA] positive). Patients with resolved infection (ie, patients who are HBsAg negative but positive for...
- Active hepatitis C infection as measured by positive hepatitis C virus (HCV)-ribonucleic acid (RNA) testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the experimental agents used in study.
- Female patient refuses to discontinue breastfeeding her infant during study treatment or within 6 months after receiving the last dose of study treatment (Section 4.11).
- Women of childbearing potential (WOCBP) and men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the...
- Highly effective contraceptive measures for women include: stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception...
- WOCBP are defined as women who are fertile following menarche until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral...
- Male study participants with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence. Male study participants should not donate sperm during the study, and for at least 6...
- Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual...
- Presence of the following cardiac conditions:
- e. New York Heart Association stage III or IV congestive heart failure
- f. Myocardial infarction or coronary artery bypass graft ≤ 6 months prior to study enrollment
- g. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration. Uncontrolled cardiac arrhythmia or clinically significant...
- h. Unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, venous thromboembolic disease, hemorrhage, pulmonary fibrosis, pneumonitis, neurological condition, active autoimmune disease...
- Active malignancy other than MM requiring treatment in the past 12 months. Malignancies treated within the past 12 months that are considered cured with minimal risk of recurrence are allowed.
- Have any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
- Patients with impaired decision-making capacity will not be enrolled on this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
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. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.