Health TrialsbyHealthPanel

ABBV-383 for the Treatment of Relapsed Refractory Waldenström Macroglobulinemia

ConditionsRecurrent Waldenstrom MacroglobulinemiaRefractory Waldenstrom Macroglobulinemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This phase I/II trial studies the side effects and best dose of ABBV-383 and to see how well it works in treating patients with Waldenström macroglobulinemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). ABBV-383 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PRE-REGISTRATION: Age ≥ 18 years

PRE-REGISTRATION: Histological confirmation of relapsed and/or refractory Waldenstrom macroglobulinemia, with known prior exposure to a Bruton tyrosine kinase (BTK) inhibitor unless medically contraindicated. Note: although not preferred, archival bone marrow tumor tissue that was collected within 12 weeks prior to screening and without intervening anti- BCMA treatment may be used if the patient is unwilling to provide a fresh pretreatment marrow biopsy

PRE-REGISTRATION: Measurable disease as defined as serum immunoglobulin M (IgM) levels ≥ 0.5 g/dL (500 mg/dL)

PRE-REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

Disqualifiers

Pregnant persons

Nursing persons

Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception

PRE-REGISTRATION: Subject has known allergic reaction, significant sensitivity, or intolerance to constituents of the study drugs (and excipients) and/or other products in the same class

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Etentamig

    Biological/Vaccine

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Treatment (ABBV-383)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD) of etentamig (ABBV-383) (Phase 1)

MTD is defined as the highest tested dose level that is determined to have acceptable toxicity and tolerability based on dose-limiting toxicity (DLT) definitions. An unacceptable dose level is one that induces DLT in at least one-third of patients (at least 2 of a maximum of 6 new patients). The MTD of ABBV-383 thus will be the highest tested dose level where at most one out of 6 patients treated have a reported DLT.

Time frame
Up to 1 cycle (Cycle length = 28 days)
2

Very good partial response (VGPR) or better response as the best response achieved (Phase 2)

The International Workshop on Waldenström's Macroglobulinemia-11 (IWWM-11) Response Criteria will be used for response assessment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Time frame
Within 12 cycles of initiation of therapy (Cycle length = 28 days)

Secondary outcomes

1

Major response rate (MRR)

Will be estimated by the total number of patients who achieve partial response (PR) or better divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true major response rate will be calculated.

Time frame
At 6 and 12 months
2

Progression-free survival (PFS)

PFS is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

Time frame
6 and 12 months
3

Time to response

Time to response is defined in patients who have achieved a response as the time from registration to the first incidence of a response. Will be summarized descriptively and will include time to the first response (defined as the time between the date of the registration and the first documented evidence of a minor response or better), major (defined as the time between the date of registration and the first documented evidence of a partial response or better), and best response during the study period.

Time frame
Up to 2 years
4

Duration of response

Duration of response is defined for all evaluable patients who have achieved an objective response as the time from which the patient's objective status is first noted to be a PR or better to the earliest date on which progressive disease or death due to any cause is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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