A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Elranatamab — DRUG
  BCMA-CD3 bispecific antibody
• Iberdomide — DRUG
  cereblon-modulating agent

Study Details

The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma. Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement. All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle. Participants will receive study medicine until: * their disease progresses or, * they experience unacceptable side effects or, * they choose to no longer take part in the study. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.

Key Dates

Start date

Feb 20, 2024

Status verified

Jun 2026

Primary completion

Apr 10, 2027

Completion

Mar 9, 2028

Study Design

Enrollment

87 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Dose Escalation
  Non-randomized elranatamab plus iberdomide
• Experimental: Part 2 Dose Randomization
  Randomized elranatamab plus iberdomide

Primary Outcome Measure

Part 1: Number of participants with dose limiting toxicity (DLT) [ Time Frame: Cycle 1, about 28 days ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (34)

Find similar trials in Coral Gables, FL

Related Studies

• Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• Collection of Samples and Clinical Data From Patients With Amyloid Diseases
  Recruiting · Boston Medical Center · Boston, Massachusetts
• Collection of Tissue Samples for Cancer Research
  Recruiting · National Cancer Institute (NCI) · Sacramento, California
• Tissue Collection for Studies of Lymph Cancer
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland