ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 19, 2024

Primary Completion Date

June 5, 2028

Study Completion Date

June 5, 2028

Conditions
Relapsed and/or Refractory Multiple Myeloma
Interventions
DRUG

ON 123300

"dosed starting at 200 mg of ON 123300 (NARAZACICLIB) daily for four weeks. Dose levels will be 160 mg, 200 mg, 240 mg, 280 mg, 320 mg. Treatment cycles will be four weeks long.~ON 123300 (NARAZACICLIB) is available as an oral formulation ON 123300 (NARAZACICLIB) monolactate capsules (containing 40 mg free base) and is provided in 120 cc high-density polyethylene (HDPE) bottles with child-resistant closures containing 30 hard gelatin capsules. ON 123300 (NARAZACICLIB) is also available in tablet form. The tablets are 40 mm (oblong) and 120 mg (round). Either form, capsules or tablets, may be used in this study."

DRUG

Dexamethasone

Weekly oral dexamethasone 20mg

Trial Locations (1)

10029

RECRUITING

Mount Sinai Health System, New York

All Listed Sponsors
lead

Adriana Rossi

OTHER

NCT06351644 - ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter