Teclistamab in Combination With Pomalidomide Administered in Alternative Fashion in Participants With Relapsed or Refractory Multiple Myeloma.

NCT07757412 | Not Yet Recruiting Phase 2

• 2 other identifiers: NMSG 40/252025-522114-23-00
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 9

Brief Summary

This Phase II, open-label, multicenter study will evaluate teclistamab in combination with pomalidomide administered using an alternative dosing approach in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy, including lenalidomide and anti-CD38 therapy. Teclistamab is a bispecific antibody that targets BCMA on myeloma cells and CD3 on T cells, bringing these cells into close proximity and activating T cells to induce targeted killing of BCMA-expressing myeloma cells. The study will assess the safety and efficacy of this treatment combination in participants with relapsed or refractory multiple myeloma.

Conditions

Multiple Myeloma Progression

Keywords

Multiple myeloma; Teclistamab; Pomalidomid; T-cell-engaging bispecific antibody

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  1 year

Study Arms (1)

Tec-Pom

EXPERIMENTAL

Drug: Teclistamab (Tec) and Pomalidomide (Pom)

Interventions

Teclistamab (Tec) and Pomalidomide (Pom) DRUG

Tec - Pom administartion in alternate fashion

Tec-Pom

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age (or the legal age of majority, if greater than 18, in the jurisdiction in which the study is taking place) at the time of informed consent.
• Documented diagnosis of multiple myeloma as defined by the criteria below:
• Multiple myeloma diagnosis according to IMWG diagnostic criteria.
• Measurable disease at screening as defined by any of the following:
• Serum M-protein level ≥0.5 g/dL; or Serum Ig FLC ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
• Relapsed or refractory disease as defined below : a. Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by IMWG criteria \>60 days after cessation of treatment. b. Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria during previous treatment or ≤60 days after cessation of treatment.
• Received 1-3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti-CD38 monoclonal antibody at the approved dosing schedule (or minimum of 6 doses if anti-CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line and 2 consecutive cycles of lenalidomide in any prior line. NOTE: A single line of therapy may consist of 1 or more agents and may include induction, hematopoietic stem cell transplantation and maintenance therapy. Radiotherapy, bisphosphonates, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 mg/day for 4 days) would not be considered prior lines of therapy.
• Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria.
• Have an ECOG performance status score of 0 to 2
• Have clinical laboratory values meeting the protocol criteria during the Screening Phase.
• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test within 14 days prior to first dose and again a negative serum pregnancy test within 24 hours of the start of study treatment and must agree to further serum pregnancy tests during the study.
• A female participant must be either of the following a. Not of childbearing potential, or b. Of childbearing potential and practicing at least 1 highly effective method of contraception.
• 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 6 months after
• A male participant must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 3 months after receiving the last dose of study treatment. If a male participant's partner is a female of childbearing potential, the male participant must use condoms (with or without spermicide) and the female partner of the male participant must also be practicing a highly effective method of contraception.
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and a period of 3 months after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment as anti-cancer treatments may impair fertility.

You may not qualify if:

• Any potential participant who meets any of the following criteria will be excluded from participating in the study:
• Received any prior BCMA-directed therapy.
• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the teclistamab IB and appropriate prescribing information).
• Participants will be excluded if intolerant to dexamethasone.
• Received the following prior antimyeloma therapy, within the specified time frame prior to enrollment:
• Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less
• Investigational vaccine within 4 weeks
• Monoclonal antibody therapy within 21 days
• Cytotoxic therapy within 21 days
• PI therapy within 14 days
• IMiD agent therapy within 14 days
• Radiotherapy within 14 days or focal radiation within 7 days
• Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
• Plasmapheresis within 28 days
• Received a maximum cumulative dose of corticosteroids of ≥140 mg of prednisone or equivalent within 14 days

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (9)

AUH

Aarhus, Denmark

Location

OUH

Odense, Denmark

Location

North Estonia Medical Centre

Tallinn, Estonia

Location

Tartu University Hospital

Tartu, Estonia

Location

Helsinki University Hospital Comprehensive Cancer Center

Helsinki, Finland

Location

Oslo University Hospital, Oslo Myeloma Centre

Oslo, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

Vestfold Hospital

Tønsberg, Norway

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Focal Adhesion Protein-Tyrosine Kinases; pomalidomide

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)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jakub Krejcik, MD, PhD

CONTACT

+4540337294; jakub.krejcik@rsyd.dk

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: July 29, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2032
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); NO (4); DK (2); ES (2)