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NCT02773030 · OUTCOME

Number of Participants With Dose Limiting Toxicities in Part 1.

A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma · Source last updated 2026-03-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose to 28 days post last dose (up to 28 days)

What was measured

The dose-limiting toxicity (DLT) population includes subjects who missed no more than 4 doses of CC-220, 2 doses of DEX, 1 dose of IV DARA (Cohort E), 1 dose of BTZ (Cohort F), or 1 dose of CFZ (Cohort G1 or G2) during Cycle 1 for reasons other than DLT. This population will be used for analyzing the primary endpoint regarding the determination of the MTD. Hematologic DLTs: Grade 4 neutropenia (ANC \<500/μL for \>5 days) Grade 3 neutropenia (ANC \<1,000/μL) with fever ≥38.5°C Grade 4 thrombocytopenia (platelet count \<25,000/μL) or Grade 3 thrombocytopenia with bleeding or need for platelet transfusion Any other grade 4 hematologic toxicity, except anemia, not resolving to pretreatment baseline within 72 hours. Non-hematologic DLT: Any non-hematological toxicity ≥ Grade 3, except alopecia and nausea controlled by medical management.

Analysis population: DLT evaluable population in Part 1. Part 1 of the study consisted of Cohorts A, B, F, G and H1 as per protocol.

Groups in this outcome

Cohort A: Treatment 1

CC220 0.30mg

Cohort A: Treatment 2

CC220 0.45mg

Cohort A: Treatment 3

CC220 0.60mg

Cohort A: Treatment 4

CC220 0.75mg

Cohort A: Treatment 5

CC220 0.90mg

Cohort A: Treatment 6

CC220 1.0mg

Cohort B: Treatment 1

CC220 0.30mg + DEX

Cohort B: Treatment 2

CC220 0.45mg + DEX

Cohort B: Treatment 3

CC220 0.60mg + DEX

Cohort B: Treatment 4

CC220 0.75mg + DEX

Cohort B: Treatment 5

CC220 0.90mg + DEX

Cohort B: Treatment 6

CC220 1.0mg + DEX

Cohort B: Treatment 7

CC220 1.1mg + DEX

Cohort B: Treatment 8

CC220 1.2mg + DEX

Cohort B: Treatment 9

CC220 1.3.mg + DEX

Cohort B: Treatment 10

CC220 1.6mg + DEX

Cohort D: Treatment 1

CC220 + DEX

Cohort E: Treatment 1

CC220 1.0mg + DARA + DEX

Cohort E: Treatment 2

CC220 1.1mg + DARA + DEX

Cohort E: Treatment 3

CC220 1.2mg + DARA + DEX

Cohort E: Treatment 4

CC220 1.3mg + DARA + DEX

Cohort E: Treatment 5

CC220 1.6mg + DARA + DEX

Cohort F: Treatment 1

CC220 1.0mg + BORT + DEX

Cohort F: Treatment 2

CC220 1.1mg + BORT + DEX

Cohort F: Treatment 3

CC220 1.3mg + BORT + DEX

Cohort F: Treatment 4

CC220 1.6mg + BORT + DEX

Cohort G: Treatment 1

CC220 1.1mg + CFZ + DEX

Cohort G: Treatment 2

CC220 1.3mg + CFZ + DEX

Cohort G: Treatment 3

CC220 1.6mg + CFZ + DEX

Cohort H1

CC220 + DEX

Cohort H2

CC220 + DEX

Cohort I

CC220 + DEX

Cohort J1: Treatment 1

CC220Vd 1.0mg + NE-ASCT

Cohort J1: Treatment 2

CC220Vd 1.6mg + NE-ASCT

Cohort K: Treatment 1

CC220 1.0mg + DARA + DEX

Cohort K: Treatment 2

CC220 1.3mg + DARA + DEX

Cohort K: Treatment 3

CC220 1.6mg + DARA + DEX

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort A: Treatment 13
Cohort A: Treatment 23
Cohort A: Treatment 33
Cohort A: Treatment 46
Cohort A: Treatment 56
Cohort A: Treatment 66
Cohort B: Treatment 13
Cohort B: Treatment 23
Cohort B: Treatment 33
Cohort B: Treatment 43
Cohort B: Treatment 53
Cohort B: Treatment 63
Cohort B: Treatment 73
Cohort B: Treatment 86
Cohort B: Treatment 96
Cohort B: Treatment 103
Cohort D: Treatment 10
Cohort E: Treatment 10
Cohort E: Treatment 20
Cohort E: Treatment 30
Cohort E: Treatment 40
Cohort E: Treatment 50
Cohort F: Treatment 13
Cohort F: Treatment 26
Cohort F: Treatment 33
Cohort F: Treatment 46
Cohort G: Treatment 13
Cohort G: Treatment 26
Cohort G: Treatment 33
Cohort H16
Cohort H20
Cohort I0
Cohort J1: Treatment 10
Cohort J1: Treatment 20
Cohort K: Treatment 10
Cohort K: Treatment 20
Cohort K: Treatment 30

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Treatment 10Not reportedNot reportedNot reportedNot reported
Cohort A: Treatment 20Not reportedNot reportedNot reportedNot reported
Cohort A: Treatment 30Not reportedNot reportedNot reportedNot reported
Cohort A: Treatment 41Not reportedNot reportedNot reportedNot reported
Cohort A: Treatment 51Not reportedNot reportedNot reportedNot reported
Cohort A: Treatment 61Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 10Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 20Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 30Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 40Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 50Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 60Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 70Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 81Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 91Not reportedNot reportedNot reportedNot reported
Cohort B: Treatment 100Not reportedNot reportedNot reportedNot reported
Cohort F: Treatment 10Not reportedNot reportedNot reportedNot reported
Cohort F: Treatment 21Not reportedNot reportedNot reportedNot reported
Cohort F: Treatment 30Not reportedNot reportedNot reportedNot reported
Cohort F: Treatment 41Not reportedNot reportedNot reportedNot reported
Cohort G: Treatment 10Not reportedNot reportedNot reportedNot reported
Cohort G: Treatment 21Not reportedNot reportedNot reportedNot reported
Cohort G: Treatment 31Not reportedNot reportedNot reportedNot reported
Cohort H11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      3
    12. group Id
      OG011
      value
      3
    units
    Participants
description
The dose-limiting toxicity (DLT) population includes subjects who missed no more than 4 doses of CC-220, 2 doses of DEX, 1 dose of IV DARA (Cohort E), 1 dose of BTZ (Cohort F), or 1 dose of CFZ (Cohort G1 or G2) during Cycle 1 for reasons other than DLT. This population will be used for analyzing the primary endpoint regarding the determination of the MTD. Hematologic DLTs: Grade 4 neutropenia (ANC \<500/μL for \>5 days) Grade 3 neutropenia (ANC \<1,000/μL) with fever ≥38.5°C Grade 4 thrombocytopenia (platelet count \<25,000/μL) or Grade 3 thrombocytopenia with bleeding or need for platelet transfusion Any other grade 4 hematologic toxicity, except anemia, not resolving to pretreatment baseline within 72 hours. Non-hematologic DLT: Any non-hematological toxicity ≥ Grade 3, except alopecia and nausea controlled by medical management.
groups
  1. description
    CC220 0.30mg
    id
    OG000
    title
    Cohort A: Treatment 1
  2. description
    CC220 0.45mg
    id
    OG001
    title
    Cohort A: Treatment 2
  3. description
    CC220 0.60mg
    id
    OG002
    title
    Cohort A: Treatment 3
  4. description
    CC220 0.75mg
    id
    OG003
    title
    Cohort A: Treatment 4
  5. description
    CC220 0.90mg
    id
    OG004
    title
    Cohort A: Treatment 5
  6. description
    CC220 1.0mg
    id
    OG005
    title
    Cohort A: Treatment 6
  7. description
    CC220 0.30mg + DEX
    id
    OG006
    title
    Cohort B: Treatment 1
  8. description
    CC220 0.45mg + DEX
    id
    OG007
    title
    Cohort B: Treatment 2
  9. description
    CC220 0.60mg + DEX
    id
    OG008
    title
    Cohort B: Treatment 3
  10. description
    CC220 0.75mg + DEX
    id
    OG009
    title
    Cohort B: Treatment 4
  11. description
    CC220 0.90mg + DEX
    id
    OG010
    title
    Cohort B: Treatment 5
  12. description
    CC220 1.0mg + DEX
    id
    OG011
    title
    Cohort B: Treatment 6
param Type
COUNT_OF_PARTICIPANTS
population Description
DLT evaluable population in Part 1. Part 1 of the study consisted of Cohorts A, B, F, G and H1 as per protocol.
reporting Status
POSTED
time Frame
From first dose to 28 days post last dose (up to 28 days)
title
Number of Participants With Dose Limiting Toxicities in Part 1.
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice