Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma

Conditions

• Relapsed and Refractory Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selinexor — DRUG
  Selinexor tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.
• Venetoclax — DRUG
  Venetoclax tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.
• Dexamethasone — DRUG
  Dexamethasone tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.

Study Details

The purpose of this research is to determine whether the combination of selinexor, venetoclax, and dexamethasone therapy can increase anti-cancer effects in patients with translocation 11;14-positive (t(11;14)), relapsed/refractory myeloma (RRMM).

Key Dates

Start date

Mar 26, 2023

Status verified

Feb 2026

Primary completion

Mar 26, 2028

Completion

Mar 26, 2030

Study Design

Enrollment

33 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: XVenD Group
  Participants will receive XVenD combination therapy of Selinexor (X), Venetoclax (Ven) and Dexamethasone (D) orally during each 28-day cycle. Doses will be administered as follows: * Cycle 1 Days 1 to 7: * Venetoclax 400 mg orally (PO), Days 1-7 * Dexamethasone 40 mg PO, Day 1 * Cycle 1 Days 8 to 28: * Venetoclax 800 mg PO, Days 8-28 * Dexamethasone 40 mg PO, Days 8, 15, and 22 * Cycles 2 to 4: * Selinexor 80 mg PO, Days 1, 8, 15, and 22 * Venetoclax 800 mg PO, Days 1-28 * Dexamethasone 40 mg PO, Days 1, 8, 15, and 22 * Cycle 5 and beyond: * Selinexor 80 mg PO, Days 1, 8, 15, and 22 * Venetoclax 800 mg PO, Days 1-28 * Dexamethasone 20 mg PO, Days 1, 8, 15, and 22 Selinexor dose will be reduced to 60 mg for remaining participants if after the first 6 participants complete the first cycle and 2 or more out of these first 6 participants experience dose-limiting toxicities (DLTs).

Primary Outcome Measure

Fraction of Participants Achieving Overall Response [ Time Frame: Up to 3 years ]

Central Contacts

• Alanna Vossen
  305-243-7701
  [email protected]
• Dickran Kazandjian, MD
  [email protected]

Locations (3)

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