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A Multicenter, Open-label Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-220 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Phase II
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT02773030
Protocol IDs
CC-220-MM-001 (primary)
NCI-2016-01463
Study Sponsor
Celgene Corporation

Summary

This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to

determine the maximum tolerated dose of CC-220 when administered as monotherapy and in

combination with dexamethasone. The study will consist of an escalating dose-escalation

portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT)

and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose

(RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).

Objectives

Subjects assigned to CC-220 monotherapy who develop PD will have the option to receive

Dexamethasone (DEX) in addition to CC-220 after consultation with the Medical Monitor. The

dose of CC-220 will not be higher than the dose of CC-220 used in combination with

dexamethasone that has been tested and is considered safe. Progressive disease must be

confirmed in accordance with International Myeloma Working Group ( IMWG) criteria.

The starting dose of DEX will be 40 mg Once daily (QD) on Days 1, 8, 15 and 22 of each

28-day cycle for subjects who are =75 years of age. For subjects who are >75 years of age,

the starting dose of DEX is 20 mg QD on Days 1, 8, 15 and 22 of each 28 day cycle. This

treatment will continue until PD, unacceptable toxicity or the subject withdraws consent.

The study will be conducted in compliance with the International Conference on Harmonisation

(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good

Clinical Practice (GCP) and applicable regulatory requirements.

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