A Study of Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed/Refractory Multiple Myeloma

Phase 1

• Conditions: Multiple Myeloma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-002169-14-HU
• Lead Sponsor: Takeda Development Center Americas, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Each patient must meet all the following criteria to be enrolled in the study:
1. Patients aged 18 years or older.
2. Documented multiple myeloma (MM) diagnosis per International Myeloma Working Group (IMWG) criteria.
3. Measurable disease, defined as at least 1 of the following:
a. Serum M protein =0.5 g/dL (=5 g/L) on serum protein electrophoresis (SPEP).
b. Urine M protein =200 mg/24 hours on urine protein electrophoresis (UPEP).
c. Serum free light chain (FLC) assay with involved FLC level =10 mg/dL (=100 mg/L) provided serum FLC ratio is abnormal.
4. For patients in the phase 1 dose escalation only:
Must have received at least 3 prior lines of therapy, including at least 1 PI, 1 IMiD, and 1 anti-CD38 mAb drug; or who are triple refractory to a PI, an IMiD, and an anti-CD38 mAb drug, regardless of the number of prior line(s) or therapy.
5. For patients in phase 2a dose finding only:
a. Received 1 to 3 prior line(s) of antimyeloma therapy.
b. Must be refractory to prior lenalidomide treatment.
c. Patients must be sensitive (nonrefractory) or naïve to prior anti-CD38 mAb treatment.
d. Documented progressive disease on or after the last regimen.
e. Patients must have PR or better to at least 1 line of prior therapy...

Please see Protocol Section 7.1 for full inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

Patients meeting any of the following criteria are not to be enrolled in the study:
1. Prior exposure to modakafusp alfa.
2. Patient has POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia, or lymphoplasmacytic lymphoma.
3. Patient has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE, Version 5 Grade =1 or baseline, except for alopecia.
4. Previous allogeneic stem cell transplant at any time or ASCT within 12 weeks of planned start of dosing...

Please see Protocol Section 7.2 for full exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified