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

NCT06207799 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0448NCI-2024-00110
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Elranatamab

EXPERIMENTAL

1. Induction therapy - This is given to decrease the number of MM cells in the bone marrow. 2. Purging - This is done to remove leftover MM cells after induction therapy. 3. Stem cell mobilization - This is done to move stem cells from your bone marrow into the blood, so they can be collected for the autologous stem cell transplant. 4. Conditioning therapy - This is given to help prepare the body to receive the stem cell transplant. 5. Autologous stem cell transplant 6. Maintenance therapy - This is given to help control the disease after the stem cell transplant.

Drug: Elranatamab; Drug: Lenalidomide; Drug: Plerixafor; Drug: Melphalan; Drug: Busulfan; Drug: G-CSF; Procedure: Stem cell transplant

Interventions

Elranatamab DRUG

Given by SC

Also known as: PF-06863135

Elranatamab

Lenalidomide DRUG

Given by PO

Also known as: CC-5013, Revlimid™

Elranatamab

Plerixafor DRUG

Given by SC

Also known as: Mobozil

Elranatamab

Busulfan DRUG

Given by PO

Also known as: Busulfex™, Myleran®

Elranatamab

G-CSF DRUG

Given by IV

Elranatamab

Stem cell transplant PROCEDURE

Given by IV

Also known as: Allogeneic stem cell transplant, Autologous stem cell transplant, Cord blood

Elranatamab

Melphalan DRUG

Given by IV

Also known as: Alkeran®, Evomela

Elranatamab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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).
• 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 Epidemiology Collaboration (CKD-EPI) formula). \*
• 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 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.
• Non Nonchildbearing potential is defined as follows (by other than medical reasons):
• ≥ 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.

You may not qualify 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 elranatamab is expected. If concomitant medication alters target expression, it can potentially impact the PK of elranatamab. Drugs like anti-thymocyte globulin (ATG) can deplete T-cells and can potentially impact the PK of drugs targeting CD3. b. Elranatamab has been shown to increase T-cell activation and induce cytokine production (including IL-2, IL-6, IL-10, TNF-alpha and IFN-gamma). Cytokines have been shown to modulate expression of CYP enzymes and transporters, therefore, elranatamab can potentially affect CYP enzyme and transporter expression levels, and consequently modulate the clearance of concomitant medications that are substrates for these enzymes or transporters. When administering elranatamab, it is important to exercise caution with concomitant medications, especially those that are sensitive substrates of the cytochrome P450 (CYP) enzyme system and have a narrow therapeutic index. Increased exposure of CYP substrates is more likely to occur after the first dose of elranatamab on Day 1 and up to 14 days after the 32 mg dose on Day 4 and during and after CRS. Examples of such medications include cyclosporine. During this critical window, it's imperative to closely monitor the toxicity or concentrations of these concomitant drugs. If necessary, dose adjustments for these co-administered drugs should be considered to ensure patient safety. c. Cytochrome P450 (CYP) enzyme system is responsible for the metabolism of a vast number of drugs. Below are examples of drugs metabolized by specific CYP enzymes that could be impacted if elranatamab alters the activity or expression of these enzymes. Exercise caution when using these drugs: i. CYP2C9 substrates:
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• \- Warfarin
• \- Phenytoin
• \- Celecoxib
• \- Losartan ii. CYP3A4 substrates:
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• \- 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:

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; plerixafor; Melphalan; Busulfan; Granulocyte Colony-Stimulating Factor; Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Proteins; Biological Factors; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Qaiser Bashir, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qaiser Bashir, MD

CONTACT

(713) 794-4422; qbashir@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)