Health TrialsbyHealthPanel

External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease

ConditionsExtramedullary Disease in Multiple MyelomaMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase I/II trial tests the safety and effectiveness of extramedullary disease (EMD)-directed external beam radiation therapy (EBRT) in combination with talquetamab for the treatment of multiple myeloma patients with extramedullary disease. Extramedullary disease in multiple myeloma involves the infiltration of organs and soft tissues by malignant plasma cells and has proven difficult to treat. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink cancers. EBRT is a type of radiation therapy that delivers high-energy beams to the cancer from outside of the body. In this trial, the EBRT will be directed to a site of extramedullary disease. Talquetamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Combining EMD-directed EBRT with talquetamab may be safe, tolerable, and/or effective in treating multiple myeloma patients with extramedullary disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

If unavailable, exceptions may be granted with study principal investigator (PI) approval

Disqualifiers

Prior irradiation to target EMD site or field

Prior GPRC5D therapy

Prior radiopharmaceutical therapy

Patients who have received previous radiation to > 25% of their bone marrow

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT and/or PET/CT

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • External Beam Radiation Therapy

    Radiation

    Undergo EMD-EBRT

  • Image Guided Biopsy

    Procedure/Surgery

    Undergo image-guided EMD biopsy

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Talquetamab

    Biological/Vaccine

    Given SC

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment (EDM-EBRT, talquetamab)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (phase 1b)

Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome. Toxicity information recorded in each patient will include the type, severity, and the probable association with the study regimen. Tabular and graphical summaries will be used to represent the observed incidence by severity and type of toxicity.

Time frame
From start of protocol therapy until cycle 1 day 28
2

Extramedullary disease (EMD)-modified overall response rate (ORR) (phase 2)

EMD-modified ORR will be defined as the proportion of patients meeting the criteria for partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR). Disease response will be evaluated per International Myeloma Working Group (IMWG) response criteria and Response Criteria for EMD. Clopper-Pearson 95% confidence intervals will be calculated for these estimates.

Time frame
Up to 12 months

Secondary outcomes

1

Progression-free survival

Will be estimated using the product-limit method of Kaplan and Meier.

Time frame
From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 12 months
2

Overall survival

Will be estimated using the product-limit method of Kaplan and Meier.

Time frame
From first day of treatment to time of death due to any cause, assessed up to 12 months
3

Duration of response

Will be evaluated in patients with PR or better. Will be estimated using the product-limit method of Kaplan and Meier.

Time frame
From first response documented until disease progression, assessed up to 12 months
4

Clinical benefit rate

Clinical benefit rate will be defined as the proportion of patients meeting the criteria for stable disease, PR, VGPR, CR, or sCR. Disease response will be evaluated per IMWG response criteria. Clopper-Pearson 95% confidence intervals will be calculated for these estimates.

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now