NCT00555906 · OUTCOME

Best Overall Response: Phase 1

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma. · Source last updated 2015-03-19

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

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Cycle 1 Day 1 (baseline), assessed on Day 1 of every cycle up to end of study (up to Cycle 22 for schedule A and schedule B)

What was measured

Best overall response: best confirmed response on study after first study dose as per IMWGURC. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, \>=90% reduction in serum M-protein, \<100 mg/24 hr urine M-protein. PR: \>=50% reduction of serum M-protein, reduction in 24-hr urinary M-protein by \>=90% or to \<200mg/24 hr. Progressive disease (PD): \>=25% increase from lowest response level in serum M-component or urine M-component, \>=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. Stable disease (SD): criteria for CR, VGPR, PR or PD not met.

Analysis population: RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.

Groups in this outcome

Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)

Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)

Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)

Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)

Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

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

Analysis denominator · Participants

Group	Source count
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	1
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	5
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	7
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	5

Reported measurements

Stringent Complete Response

Values in participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	Not reported	Not reported	Not reported	Not reported
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	Not reported	Not reported	Not reported	Not reported
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	Not reported	Not reported	Not reported	Not reported
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	Not reported	Not reported	Not reported	Not reported

Complete Response

Values in participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	Not reported	Not reported	Not reported	Not reported
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	Not reported	Not reported	Not reported	Not reported
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	Not reported	Not reported	Not reported	Not reported
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	Not reported	Not reported	Not reported	Not reported

Very Good Partial Response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	0	Not reported	Not reported	Not reported	Not reported
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	1	Not reported	Not reported	Not reported	Not reported
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	0	Not reported	Not reported	Not reported	Not reported
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	1	Not reported	Not reported	Not reported	Not reported

Partial Response

Values in participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	Not reported	Not reported	Not reported	Not reported
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	Not reported	Not reported	Not reported	Not reported
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	Not reported	Not reported	Not reported	Not reported
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	Not reported	Not reported	Not reported	Not reported

Stable Disease

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	0	Not reported	Not reported	Not reported	Not reported
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	1	Not reported	Not reported	Not reported	Not reported
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	4	Not reported	Not reported	Not reported	Not reported
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	2	Not reported	Not reported	Not reported	Not reported

Progressive Disease

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	1	Not reported	Not reported	Not reported	Not reported
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	3	Not reported	Not reported	Not reported	Not reported
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	3	Not reported	Not reported	Not reported	Not reported
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	1	Not reported	Not reported	Not reported	Not reported

Indeterminate

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	0	Not reported	Not reported	Not reported	Not reported
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)	0	Not reported	Not reported	Not reported	Not reported
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	0	Not reported	Not reported	Not reported	Not reported
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

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Stringent Complete Response
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units
Participants

description

groups

description
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
id
OG000
title
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
description
Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
id
OG001
title
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
description
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
id
OG002
title
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
description
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
id
OG003
title
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)

param Type

NUMBER

population Description

RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.

reporting Status

POSTED

time Frame

Cycle 1 Day 1 (baseline), assessed on Day 1 of every cycle up to end of study (up to Cycle 22 for schedule A and schedule B)

title

Best Overall Response: Phase 1

type

SECONDARY

unit Of Measure

participants

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Preserved source evidence · Not medical advice