A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Modakafusp alfa — DRUG
  Modakafusp alfa intravenous infusion.
• Lenalidomide — DRUG
  Lenalidomide capsules orally.
• Bortezomib — DRUG
  Bortezomib injection subcutaneously.
• Carfilzomib — DRUG
  Carfilzomib intravenous infusion.
• Daratumumab — DRUG
  Daratumumab injection subcutaneously.
• Pomalidomide — DRUG
  Pomalidomide capsules orally.

Study Details

The main aims of this study are to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp alfa. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Participants will be given modakafusp alfa through a vein.

Key Dates

Start date

Jan 12, 2023

Status verified

Jan 2026

Primary completion

Jun 4, 2024

Completion

Jun 4, 2024

Study Design

Enrollment

15 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
  Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD \[-\]) participants, whichever occurred first.
• Experimental: Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
  Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
• Experimental: Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
  Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
• Experimental: Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
  Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
• Experimental: Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Bortezomib
  Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with bortezomib injection subcutaneously on Days 8, 15, and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
• Experimental: Group 3 (RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib
  Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle along with bortezomib injection subcutaneously on Days 8, 15 and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
• Experimental: Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide
  Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with daratumumab injection subcutaneously on Days 1, 8, 15 and 22 of Cycles 1 and 2, further followed by on Days 1 and 15 of Cycles 3 to 6, thereafter on Day 1 on a 28-day (4-week) treatment cycle along with pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Cycle length is 28 days) ]

Locations (14)

Find similar trials in Sacramento, CA

Related Studies

• Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• Collection of Tissue Samples for Cancer Research
  Recruiting · National Cancer Institute (NCI) · Sacramento, California
• Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
  Recruiting · Ohio State University Comprehensive Cancer Center · Columbus, Ohio
• Tissue Collection for Studies of Lymph Cancer
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland