Multiple Myeloma Clinical Trial
A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Summary
This study will test the safety and efficacy of FOR46 given every 21 days to patients with relapsed or refractory multiple myeloma.
The name of the study drug involved in this study is: FOR46 for Injection
Full Description
This study is designed to evaluate the safety, tolerability and antitumor activity of FOR46 in patients with relapsed or refractory multiple myeloma. This study will be conducted in two parts:
Dose escalation:
This part will evaluate increasing doses of FOR46 to identify the maximum tolerated dose (MTD). The first patient enrolled on the study will receive the lowest dose of FOR46. Once this dose is shown to be safe, a second patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD is reached.
Dose expansion:
This part of the study will further evaluate the safety, tolerability and antitumor activity of FOR46 at a dose shown to be safe in the dose escalation part of the study.
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 18 years of age
Measurable MM that is relapsed or refractory to established therapies with known clinical benefit in RRMM or intolerant of those established MM therapies. Prior lines of therapy must include a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD) and a CD38-directed therapy in any order of combination.
ECOG performance status of 0 or 1
Adequate hematologic, renal and hepatic function
Females of child-bearing potential must have a negative serum pregnancy test and use a medically acceptable form of contraception
Male patients with with female partners of childbearing potential must agree to use 2 effective methods of contraception
Patients must provide signed informed consent
Exclusion Criteria:
Persistent clinically significant toxicities from previous anticancer therapy
NCI CTCAE Grade ≥ 2 peripheral neuropathy from any etiology or has a genetic disorder that is associated with peripheral neuropathy even without current neuropathic manifestations
Has received treatment with a stem cell transplant within 12 weeks before administration of patient's first dose of FOR46
Has had radiation or systemic anticancer therapy within 14 days before first dose of FOR46
Has received treatment with an investigational drug within 28 days before first dose of FOR46
Has had a major surgical procedure within 28 days before administration of the patient's first FOR46 dose
Is breastfeeding
Clinically significant cardiovascular disease
Uncontrolled, clinically significant pulmonary disease
Uncontrolled intercurrent illness
Has known positive status for HIV or either active/chronic hepatitis B/C
Requires anticoagulation with warfarin or direct thrombin inhibitor; a washout of 7 days before the administration of a patient's first FOR46 dose is required for patients removed from these treatments
Requires medications that are strong inhibitors or strong inducers of CYP3A4
Has a history of episodic atrial fibrillation or flutter; patients with chronic atrial fibrillation are not excluded.
Prior treatment with an ADC containing Monomethyl auristatin E (MMAE) or Monomethyl auristatin F (MMAF).
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There are 7 Locations for this study
San Francisco California, 94143, United States
Aurora Colorado, 80045, United States
Atlanta Georgia, 30322, United States
Baltimore Maryland, 21231, United States
Detroit Michigan, 48201, United States
Saint Louis Missouri, 63310, United States
New York New York, 10029, United States
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