Clinical trial for Multiple Myeloma
Official title ERd Combination Treatment in Newly Diagnosed Multiple Myeloma (ADVANCE 2.0)
ClinicalTrials.gov ID: NCT06997081
What this study is testing
What is Lenalidomide?
Lenalidomide is an investigational medicine, taken by mouth, 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
- This study is testing whether adding Elranatamab to Lenalidomide and Dexamethasone helps people newly diagnosed with multiple myeloma.
- Who it's for
- You may be able to join if you have just been diagnosed with multiple myeloma.
- What's involved
- You will receive Elranatamab, Lenalidomide, and Dexamethasone as prescribed. You will have regular visits and blood tests to monitor your health.
- Time commitment
- The study lasts several months and requires you to attend scheduled clinic visits and follow the medication schedule.
- 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
- Serum monoclonal protein ≥ 1.0 g/dL
- Urine monoclonal protein ≥ 200 mg/24 hour
- Patients who have evaluable disease based on samples other than urine do not need to have urine evaluated for initial or subsequent response...
- Because the primary endpoint is MRD negativity rate, per the discretion of the Principal Investigator (PI), patients without measurable disease...
- Hypercalcemia: serum calcium \>0.25 mmol/L (\>1.0 mg/dL) above upper limit of normal (ULN) or ≥2.75 mmol/L (11 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.
- Adult male and female participants ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Refer to Appendix A)
- 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
- Hemoglobin \>8 g/dL (transfusions are permissible if the cause of the anemia is other than myeloma)
See the full eligibility criteria
Who can join
- Serum monoclonal protein ≥ 1.0 g/dL
- Urine monoclonal protein ≥ 200 mg/24 hour
- Patients who have evaluable disease based on samples other than urine do not need to have urine evaluated for initial or subsequent response assessments.
- Because the primary endpoint is MRD negativity rate, per the discretion of the Principal Investigator (PI), patients without measurable disease (e.g., M-spike \<1.0 g/dL) may also be enrolled in line with the...
- Hypercalcemia: serum calcium \>0.25 mmol/L (\>1.0 mg/dL) above upper limit of normal (ULN) or ≥2.75 mmol/L (11 mg/dL)
- Anemia: hemoglobin value \ 2 g/dL below lower limit of normal (LLN)
- Bone disease: ≥1 lytic lesions on skeletal X-ray, computed tomography (CT), or positron emission tomography (PET)-CT. For patients with 1 lytic lesion, bone marrow should demonstrate ≥10% clonal plasma cells
- Clonal bone marrow plasma cell percentage ≥60%
- Involved/un-involved serum free light chain ratio ≥100 and involved free light chain ≥100 mg/L.
- \>1 focal lesion on magnetic resonance imaging study (lesion must be \>5 mm) in size
- For patients with 1 lytic lesion, bone marrow should demonstrate ≥10% clonal plasma cells
- 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 IMWG
- Participants who have evaluable disease based on samples other than urine do not need to have urine evaluated for subsequent responses.
- In participants who received minimal prior therapy within the allowable range per
What rules you out
- 1, patients should have had documented measurable disease within 4 weeks of starting that respective therapy if currently unmeasurable.
- Adult male and female participants ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Refer to Appendix A)
- 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
- GFR ≥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.
- Participants must be willing, able, and agree to enrolling in the lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program.
- 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 and must...
- Not of childbearing potential, or
- Of childbearing potential and practicing at least 1 highly effective method of contraception as described in Section 5.7
- 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 at least 4 weeks after the last dose of lenalidomide or 4...
- A female participant must agree to not breastfeed during the study and for a period of at least 4 weeks after the last dose of lenalidomide or 4 months after the last dose of elranatamab.
- 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 at least 4 weeks after receiving the last dose of study...
- 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.
- 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.
- Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted
- Bone targeting agents are permitted
- Concurrent or prior treatment with corticosteroids for indications other than multiple myeloma is permitted
- Prior MM treatments, such as immunomodulatory drugs (IMIDs) or non-MM drugs in clinical trials for smoldering myeloma is permitted with a washout period of 2 weeks from last dose.
- Patients with measurable disease who received up to one cycle of any therapy within 60 days with a washout period of 2 weeks from last dose (on a trial or outside a trial) are eligible (Note: Measurable disease is...
- Known active central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement
- Major surgery within 14 days prior to enrollment
- Peripheral neuropathy (PN)/history of PN ≥ 3
- Patients who are receiving any other anti-myeloma investigational agents.
- 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 or during to...
- History of acquired immune deficiency syndrome (AIDS)-defining conditions cluster of differentiation 4 (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).
- 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.
- Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal.
- Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification.
- Severe acute respiratory syndrome (SARS) coronavirus (COV) 2 (SARS-CoV-2) PCR testing is mandated within 5 days prior to enrollment. Exclusion if positive or suspected infection.
- 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 3 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.
- 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 3 years. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma...
- 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 is enrolling
- 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, 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 Miami, Florida, United States. 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.