RECRUITING

Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma

Conditions

Multiple Myeloma Post-transplant MRD-guided Maintenance Therapy Pre-transplant Purging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pre-transplant Purging and Post-transplant MRD-guided Maintenance Therapy With Elranatamab in Patients With High-risk Multiple Myeloma

Quick Facts

Study Start:2024-07-17

Study Completion:2031-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06207799

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Transplant eligible patients with newly diagnosed multiple myeloma (NDMM). 2. High-risk multiple myeloma\* 3. Participants with disease response ≥ PR to induction therapy 4. Age ≥ 18 and ≤ 75. Non-English-speaking participants are eligible. 5. Karnofsky performance status ≥70 (Appendix A). 6. Adequate liver function (total bilirubin ≤1.5X ULN; ALT ≤2.5 X ULN) 7. 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 Epidemiology Collaboration (CKD-EPI) formula). \* 8. Participant agrees to not donate blood while taking lenalidomide and for 28 days after stopping lenalidomide. 9. Participant agrees to enroll in the lenalidomide REMS program. 10. 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 dependency (as described in Appendix B), plus one additional effective method at least 28 days before starting therapy, during the intervention period, at least 28 days after the last dose of lenalidomide and at least 4 months after the last dose of elranatamab, and agrees not to donate eggs (ova, oocytes) for reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relation to the first dose of the study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 10-14 days and also within 24 hours before the first dose of the study intervention. * ≥ 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. 11. 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 clearance of any altered sperm: - Refrain from donating sperm during treatment (including dose interruptions) and for 4 weeks after their last dose of lenalidomide and 4 months after the last dose of elranatamab. * 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: * Ultra-high-risk MM * Presence of ≥2 HRCA.	1. - Warfarin 2. - Phenytoin 3. - Celecoxib 4. - Losartan ii. CYP3A4 substrates: 1. - Statins: simvastatin, atorvastatin, lovastatin 2. - Calcineurin inhibitors: cyclosporine, tacrolimus 3. - Antiretroviral drugs: ritonavir, saquinavir, nelfinavir 4. - Benzodiazepines: diazepam, alprazolam 5. - Calcium channel blockers: nifedipine, verapamil, diltiazem 6. - Macrolide antibiotics: erythromycin, clarithromycin iii. CYP2D6 substrates: 1. - Antipsychotics: aripiprazole, risperidone, haloperidol 2. - Tricyclic antidepressants: amitriptyline, nortriptyline, imipramine 3. - Beta-blockers: metoprolol, propranolol, carvedilol 4. - Codeine 5. - Tamoxifen iv. CYP1A2 substrates: 1. - Theophylline 2. - Fluvoxamine 3. - Clozapine v. CYP2C19 substrates: 1. - Omeprazole 2. - Citalopram 3. - Diazepam d. For participants on digoxin, monitor digoxin plasma levels periodically with the concomitant use of lenalidomide. Refer to lenalidomide USPI for additional information. * 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 Hepatitis B and/or C infection. • Participant must not have invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction. • Participants must not be pregnant or lactating. • Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.

Inclusion Criteria

Exclusion Criteria

1. Transplant eligible patients with newly diagnosed multiple myeloma (NDMM).
2. High-risk multiple myeloma\*
3. Participants with disease response ≥ PR to induction therapy
4. Age ≥ 18 and ≤ 75. Non-English-speaking participants are eligible.
5. Karnofsky performance status ≥70 (Appendix A).
6. Adequate liver function (total bilirubin ≤1.5X ULN; ALT ≤2.5 X ULN)
7. 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 Epidemiology Collaboration (CKD-EPI) formula). \*
8. Participant agrees to not donate blood while taking lenalidomide and for 28 days after stopping lenalidomide.
9. Participant agrees to enroll in the lenalidomide REMS program.
10. 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 dependency (as described in Appendix B), plus one additional effective method at least 28 days before starting therapy, during the intervention period, at least 28 days after the last dose of lenalidomide and at least 4 months after the last dose of elranatamab, and agrees not to donate eggs (ova, oocytes) for reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relation to the first dose of the study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 10-14 days and also within 24 hours before the first dose of the study intervention.
* ≥ 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.
11. 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 clearance of any altered sperm: - Refrain from donating sperm during treatment (including dose interruptions) and for 4 weeks after their last dose of lenalidomide and 4 months after the last dose of elranatamab.
* 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:
* Ultra-high-risk MM
* Presence of ≥2 HRCA.

1. - Warfarin
2. - Phenytoin
3. - Celecoxib
4. - Losartan ii. CYP3A4 substrates:
1. - Statins: simvastatin, atorvastatin, lovastatin
2. - Calcineurin inhibitors: cyclosporine, tacrolimus
3. - Antiretroviral drugs: ritonavir, saquinavir, nelfinavir
4. - Benzodiazepines: diazepam, alprazolam
5. - Calcium channel blockers: nifedipine, verapamil, diltiazem
6. - Macrolide antibiotics: erythromycin, clarithromycin iii. CYP2D6 substrates:
1. - Antipsychotics: aripiprazole, risperidone, haloperidol
2. - Tricyclic antidepressants: amitriptyline, nortriptyline, imipramine
3. - Beta-blockers: metoprolol, propranolol, carvedilol
4. - Codeine
5. - Tamoxifen iv. CYP1A2 substrates:
1. - Theophylline 2. - Fluvoxamine 3. - Clozapine v. CYP2C19 substrates:
1. - Omeprazole
2. - Citalopram
3. - Diazepam d. For participants on digoxin, monitor digoxin plasma levels periodically with the concomitant use of lenalidomide. Refer to lenalidomide USPI for additional information.
* 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 Hepatitis B and/or C infection. • Participant must not have invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction. • Participants must not be pregnant or lactating. • Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.

Contacts and Locations

Study Contact

Qaiser Bashir, MD

CONTACT

(713) 794-4422

qbashir@mdanderson.org

Principal Investigator

Qaiser Bashir, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Qaiser Bashir, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-17

Study Completion Date2031-12-31

Study Record Updates

Study Start Date2024-07-17

Study Completion Date2031-12-31

Terms related to this study

Additional Relevant MeSH Terms

Multiple Myeloma
Post-transplant MRD-guided Maintenance Therapy
Pre-transplant Purging