BridgeMD
New treatment option for Multiple Myeloma
Official title Teclistamab in Combination With Daratumumab for High-Risk Smoldering Myeloma: A Clinical and Correlative Phase 2 Immuno-Oncology Study (the REVIVE Study)
ClinicalTrials.gov ID: NCT06100237
What this study is testing
What is Teclistamab?
Teclistamab is an investigational medicine, given as an injection under the skin, 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 see whether combination treatment of Teclistamab and Daratumumab (Tel-Dara) or combination Talquetamab and Daratumumab (Tal-Dara) will delay the onset of multiple myeloma.
- 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
- Patients must have histologically or cytologically confirmed smoldering multiple myeloma (SMM) based on the IMWG Criteria10 including:
- Serum M-protein ≥3 g/dL and/or BMPCs≥10 % (but \<60%)
- Absence of anemia: hemoglobin \>10 g/dL
- Absence of renal failure: serum creatinine \<2.0 mg/dL
- Absence of hypercalcemia: Calcium \<10.5 mg/dL
You likely can't join if
- 1, patients should have had documented measurable disease within 4 weeks of starting that respective therapy if currently unmeasurable.
- Patients age ≥18 years.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 assessed within the past 45 days. (See Appendix 17.1).
- Patients must have adequate organ and marrow function ≤45 days as defined below:
- Absolute neutrophil count (ANC) \>1.0 K cells/μL; At the discretion of the Investigator, patients with an ANC of 0.5 K/μL-1.0 K/μL may also be...
- Platelet count \>75 K cells/μL
See the full eligibility criteria
Who can join
- Patients must have histologically or cytologically confirmed smoldering multiple myeloma (SMM) based on the IMWG Criteria10 including:
- Serum M-protein ≥3 g/dL and/or BMPCs≥10 % (but \<60%)
- Absence of anemia: hemoglobin \>10 g/dL
- Absence of renal failure: serum creatinine \<2.0 mg/dL
- Absence of hypercalcemia: Calcium \<10.5 mg/dL
- Absence of lytic bone lesion on X-ray, CT, or positron emission tomography (PET)/CT and not more than 1 lesion on whole body MRI (NOTE: At the discretion of the Investigator, whole body CT or PET/CT may replace MRI in...
- Involved/uninvolved light chain ratio \<100 (unless involved light chain is ≤10 mg/dL) NOTE: Anemia, renal failure, and hypercalcemia is allowed if deemed unrelated to multiple myeloma (MM), see organ function criteria...
- Patients must have measurable disease within the past 4 weeks, which is defined by any one of the following:
- Serum monoclonal protein ≥ 0.5 g/dL
- Urine monoclonal protein \>200 mg/24 hour
- Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal kappa/lambda serum free light chain ratio (reference: 0.26-1.65)
- Other measurable disease as defined by the International Myeloma Working Group (IMWG).
- Because the primary endpoint is MRD negativity based on bone marrow analysis, a patient without measurable disease in blood or urine may be enrolled and assessed for MRD negativity. NOTE: In patients who received...
What rules you out
- 1, patients should have had documented measurable disease within 4 weeks of starting that respective therapy if currently unmeasurable.
- Patients age ≥18 years.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 assessed within the past 45 days. (See Appendix 17.1).
- Patients must have adequate organ and marrow function ≤45 days as defined below:
- Absolute neutrophil count (ANC) \>1.0 K cells/μL; At the discretion of the Investigator, patients with an ANC of 0.5 K/μL-1.0 K/μL may also be enrolled if clinically appropriate (eg, patients with a baseline neutropenia...
- Platelet count \>75 K cells/μL
- Hemoglobin \>8 g/dL (transfusions are permissible if the cause of the anemia is other than myeloma)
- Total bilirubin \<1.5 X upper limit of normal (ULN). NOTE: Isolated total bilirubin ≥1.5 X ULN with conjugated [direct] bilirubin \<1.5 X ULN is allowed for those participants with known Gilbert's syndrome.
- Aspartate aminotransferase (AST)/ alanine transaminase (ALT) ≤2.5 X ULN
- ≥30 mL/min based on Modification of Diet in Renal Disease (MDRD) 4-variable Formula calculation (Appendix 17.2) or creatine clearance (CrCl) measured by a 24-hour urine collection. The estimated glomerular filtration...
- Patients must have SMM that is categorized as high-risk for progression to MM-related end- organ damage by both clinical and genomic characteristics. Patients may be categorized as high risk by the Program for Study and...
- Serum M protein ≥3 g/dL
- Immunoglobulin A (IgA) SMM
- Immunoparesis with reduction of 2 uninvolved immunoglobulin isotypes
- Serum involved/uninvolved free light chain (FLC) ratio ≥8 (but \<100)
- Progressive increase in M-protein level (evolving type of SMM; increase in serum M- protein by ≥25% on 2 successive evaluations within a 6-month period)
- Clonal bone marrow plasma cells (BMPC) 50%-59%
- Abnormal plasma cell (PC) immunophenotype (≥95% of BMPCs are clonal) and reduction of ≥1 uninvolved immunoglobulin isotype(s)
- Chromosomal abnormalities specifically translocation of chromosomes 4 or 14 (t(4;14)) or deletion of the short arm of chromosome 17 del(17p)) or gain of the long arm of chromosome 1 (1q gain) found in ≥5% of cells
- Increased circulating PCs (PCs \>5 x 106/L and/or \>5% PCs per 100 peripheral blood mononuclear cells (PBMCs)
- MRI with diffuse abnormalities or 1 focal lesion, AND/OR PET-CT with focal lesion with increased uptake without underlying osteolytic bone destruction.
- A female participant of childbearing potential must have a negative serum or urine pregnancy test at screening (at or within 45 days of study enrollment) and within 72 hours of the start of study treatment (Section 4.7)...
- A female participant must be (as defined in Appendix 17.3):
- Not of childbearing potential, or
- Of childbearing potential and practicing at least 1 highly effective method of contraception (see Appendix 17.3). NOTE: Participant must agree to continue the above throughout the study and for 3 months after the last...
- A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of study...
- A female participant must agree to not breastfeed during the study and for a period of 5 months after receiving the last dose of study treatment.
- A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for a period of 3 months after receiving the last dose of study treatment...
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for period of 3 months after receiving the last dose of study treatment. Male participants should consider...
- Ability of the patient to understand and the willingness to sign a written informed consent document.
- 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.
- Must be willing and able to adhere to the lifestyle restrictions specified in this protocol (Section 3.3). Exclusion Criteria:
- Patients who have received prior systemic therapies for SMM/MM. One prior cycle (4-5 weeks) of therapy for SMM is allowed provided that patient undergoes a 4-week washout period prior to first dose of study treatment...
- 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:
- History of acquired immune deficiency syndrome (AIDS)-defining conditions cluster of differentiation (CD4)count \<350 cells/mm3
- Detectable viral load during screening or within 6 months prior to screening
- Not receiving highly active anti-retroviral therapy
- Had a change in antiretroviral therapy within 6 months of the start of screening
- Receiving antiretroviral therapy that may interfere with study treatment as assessed after discussion with the Medical Monitor
- Hepatitis B infection (ie, hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV)- DNA positive). Patients with resolved infection (ie, patients who are HBsAg negative but positive for antibodies to hepatitis B...
- Active hepatitis C infection as measured by positive HCV-ribonucleic acid (RNA) testing. Participants with a history of hepatitis C virus (HCV) antibody positivity must undergo HCV-RNA testing (Section 10.3.5.2.2). If a...
- Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal. Note that FEV1 testing is required for participants with known or suspected of having COPD or...
- Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that FEV1 testing is required for participants with known or suspected asthma, and participants must be...
- 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 5 months after receiving the last dose of study treatment.
- Participant plans to father a child while enrolled in this study or within 3 months after the last dose of study treatment.
- Presence of the following cardiac conditions:
- New York Heart Association stage III or IV congestive heart failure
- Myocardial infarction or coronary artery bypass graft ≤6 months prior to study enrollment
- 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 electrocardiogram (ECG) abnormalities
- 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, active autoimmune disease or a documented history...
- Active malignancy other than SMM requiring treatment in the past 24 months. Malignancies treated within the past 24 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.