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New treatment option for Multiple Myeloma
Official title Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma
ClinicalTrials.gov ID: NCT06207799
What this study is testing
What is Elranatamab?
Elranatamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as PF-06863135.
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
- To learn if giving elranatamab before and after an autologous stem cell transplant (ASTC) can help to control newly diagnosed, high-risk MM. An ASTC is a type of transplant in which a person's own stem cells are collected, preserved, and returned to them.
- 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 to 75
You may be able to join if
- Transplant eligible patients with newly diagnosed multiple myeloma (NDMM).
- High-risk multiple myeloma\
- Participants with disease response ≥ PR to induction therapy
- Age ≥ 18 and ≤ 75. Non-English-speaking participants are eligible.
- Karnofsky performance status ≥70 (Appendix A).
You likely can't join if
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to elranatamab or other agents used in study.
- Drug interactions (Prohibited unless considered medically necessary): a. At projected clinical doses, TMDD (target mediated drug disposition) of...
- \- Warfarin
- \- Phenytoin
- \- Celecoxib
- \- Losartan ii. CYP3A4 substrates:
See the full eligibility criteria
Who can join
- Transplant eligible patients with newly diagnosed multiple myeloma (NDMM).
- High-risk multiple myeloma\
- Participants with disease response ≥ PR to induction therapy
- Age ≥ 18 and ≤ 75. Non-English-speaking participants are eligible.
- Karnofsky performance status ≥70 (Appendix A).
- Adequate liver function (total bilirubin ≤1.5X ULN; ALT ≤2.5 X ULN)
- Estimated creatinine clearance ≥40 mL/min. Creatinine clearance may be calculated using Cockcroft-Gault, estimated glomerular filtration rate (Modification of Diet in Renal Disease [MDRD]), or Chronic Kidney Disease...
- Participant agrees to not donate blood while taking lenalidomide and for 28 days after stopping lenalidomide.
- Participant agrees to enroll in the lenalidomide REMS program.
- Women of child-bearing potential (WOCPB) must abstain from heterosexual intercourse or agree to use a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user...
- ≥ 45 years of age and has not had menses for \>1 year.
- Participants who have been amenorrhoeic for \<2 years without a history of a hysterectomy and oophorectomy must have a follicle-stimulating hormone value in the postmenopausal range upon screening evaluation.
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.
- Male participant agrees to contraceptive use that should be consistent with institutional guidelines regarding the methods of contraception for those participating in clinical studies.
- Male participants are eligible to participate if they agree to the following during the intervention period and for 1 (for lenalidomide) to 4 (for elranatamab) months after the last dose of study treatment to allow for...
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
- Must agree to use contraception/barrier as detailed in Appendix B. \ Definition of high-risk and ultra-high-risk MM15:
- High-risk MM: o Presence of a high-risk chromosomal abnormality (HRCA) including: 17p13 deletion; t(4;14); t(14;16); t(14;20); Gain or amplification 1q by FISH.
- Ultra-high-risk MM
- Presence of ≥2 HRCA.
What rules you out
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to elranatamab or other agents used in study.
- Drug interactions (Prohibited unless considered medically necessary): a. At projected clinical doses, TMDD (target mediated drug disposition) of elranatamab is expected. If concomitant medication alters target...
- \- Warfarin
- \- Phenytoin
- \- Celecoxib
- \- Losartan ii. CYP3A4 substrates:
- \- Statins: simvastatin, atorvastatin, lovastatin
- \- Calcineurin inhibitors: cyclosporine, tacrolimus
- \- Antiretroviral drugs: ritonavir, saquinavir, nelfinavir
- \- Benzodiazepines: diazepam, alprazolam
- \- Calcium channel blockers: nifedipine, verapamil, diltiazem
- \- Macrolide antibiotics: erythromycin, clarithromycin iii. CYP2D6 substrates:
- \- Antipsychotics: aripiprazole, risperidone, haloperidol
- \- Tricyclic antidepressants: amitriptyline, nortriptyline, imipramine
- \- Beta-blockers: metoprolol, propranolol, carvedilol
- \- Codeine
- \- Tamoxifen iv. CYP1A2 substrates: 1\. - Theophylline 2. - Fluvoxamine 3. - Clozapine v. CYP2C19 substrates:
- \- Omeprazole
- \- Citalopram
- \- Diazepam d. For participants on digoxin, monitor digoxin plasma levels periodically with the concomitant use of lenalidomide. Refer to lenalidomide USPI for additional information.
- History of progressive disease at any time before starting maintenance.
- Participants with non-secretory MM (no measurable disease on electrophoresis and immunofixation). Participants with a measurable disease on PET scan or bone marrow will be eligible.
- Participants with Waldenströms macroglobulinemia.
- Participants with POEMS syndrome.
- Participants with smoldering MM (IMWG criteria)
- Participants with plasma cell leukemia.
- Participants with standard-risk MM.
- Participants with relapsed and/or refractory MM.
- Participant must not have presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM...
- Participant must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable...
- Uncontrolled and active pulmonary disease.
- Participant must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or five half-lives, whichever is shorter, preceding the first dose of study...
- Participant must not have any evidence of active mucosal or internal bleeding.
- Participant must not have an uncontrolled infection.
- Participant must not have evidence of cardiovascular risk, including any of the following:
- Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.
- History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
- Class III or IV heart failure as defined by the New York Heart Association functional classification system.16
- Uncontrolled hypertension (blood pressure that remains above goal despite the concurrent use of three antihypertensive drug classes). Participant must not have known HIV infection. Participant must not have active...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.