NCT00555906 · OUTCOME

Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2

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: MEAN
Unit: units on a scale
Interval / dispersion: 95% Confidence Interval
Time frame: C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)

What was measured

The QLQ-MY20 consisted of 20 items addressing 4 domains of health-related quality of life (HRQoL) important to participants with multiple myeloma: future perspective (2 items), pain/disease symptoms (6 items), social support /body image (2 items), and treatment side-effects (10 items). All items used 4 point scale (1 'Not at all' to 4 'Very much'). Scores for HRQoL domains were calculated as an average of the individual items, transformed to 0 to 100 range. Higher scores on symptom scales (disease symptoms and side effects of treatment) indicated a higher level of symptoms/problems. Higher scores on functional scales (future perspective and body image) indicated a higher level of QoL/functioning.

Analysis population: PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at spefied time points for each arm, respectively.

Groups in this outcome

Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2: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 2 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(Phase2:Schedule B)	27

Reported measurements

C1D1: Disease Symptoms (n=27)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	35.68	Not reported	25.5	45.9	Not reported

C1D1: Side Effects of Treatment (n=27)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.61	Not reported	17.7	33.5	Not reported

C1D1: Future Perspective (n=27)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	46.50	Not reported	36.4	56.6	Not reported

C1D1: Body Image (n=27)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	24.69	Not reported	11.2	38.2	Not reported

C1D8: Disease Symptoms (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	35.51	Not reported	25.3	45.7	Not reported

C1D8: Side Effects of Treatment (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	23.90	Not reported	16.1	31.7	Not reported

C1D8: Future Perspective (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	44.44	Not reported	32.9	56.0	Not reported

C1D8: Body Image (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	13.33	Not reported	3.6	23.1	Not reported

C1D15: Disease Symptoms (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	32.31	Not reported	22.7	41.9	Not reported

C1D15: Side Effects of Treatment (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	26.89	Not reported	19.8	33.9	Not reported

C1D15: Future Perspective (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	48.89	Not reported	37.0	60.7	Not reported

C1D15: Body Image (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	28.00	Not reported	14.4	41.6	Not reported

C2D1: Disease Symptoms (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	29.82	Not reported	21.4	38.3	Not reported

C2D1: Side Effects of Treatment (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	24.73	Not reported	18.5	31.0	Not reported

C2D1: Future Perspective (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	46.22	Not reported	35.0	57.4	Not reported

C2D1: Body Image (n=25)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	17.33	Not reported	7.5	27.2	Not reported

C3D1: Disease Symptoms (n=21)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.13	Not reported	16.2	34.0	Not reported

C3D1: Side Effects of Treatment (n=21)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.01	Not reported	18.1	31.9	Not reported

C3D1: Future Perspective (n=21)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	44.44	Not reported	31.7	57.1	Not reported

C3D1: Body Image (n=21)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	20.63	Not reported	10.5	30.8	Not reported

C4D1: Disease Symptoms (n=18)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	28.71	Not reported	17.8	39.6	Not reported

C4D1: Side Effects of Treatment (n=18)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	26.64	Not reported	18.0	35.3	Not reported

C4D1: Future Perspective (n=18)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	44.45	Not reported	28.7	60.2	Not reported

C4D1: Body Image (n=18)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.93	Not reported	8.4	43.5	Not reported

C5D1: Disease Symptoms (n=17)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	27.78	Not reported	15.2	40.3	Not reported

C5D1: Side Effects of Treatment (n=17)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	27.52	Not reported	19.1	36.0	Not reported

C5D1: Future Perspective (n=17)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	45.75	Not reported	29.1	62.4	Not reported

C5D1: Body Image (n=17)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.49	Not reported	11.2	39.7	Not reported

C6D1: Disease Symptoms (n=15)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	24.08	Not reported	14.0	34.1	Not reported

C6D1: Side Effects of Treatment (n=15)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.04	Not reported	15.2	34.9	Not reported

C6D1: Future Perspective (n=15)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	40.74	Not reported	22.2	59.3	Not reported

C6D1: Body Image (n=15)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	20.00	Not reported	1.8	38.2	Not reported

C7D1: Disease Symptoms (n=11)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.96	Not reported	11.8	40.2	Not reported

C7D1: Side Effects of Treatment (n=11)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	26.77	Not reported	11.5	42.0	Not reported

C7D1: Future Perspective (n=11)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	44.44	Not reported	23.1	65.8	Not reported

C7D1: Body Image (n=11)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	30.30	Not reported	9.2	51.4	Not reported

C8D1: Disease Symptoms (n=10)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	18.56	Not reported	9.3	27.8	Not reported

C8D1: Side Effects of Treatment (n=10)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	26.41	Not reported	9.8	43.0	Not reported

C8D1: Future Perspective (n=10)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	35.56	Not reported	15.8	55.3	Not reported

C8D1: Body Image (n=10)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	30.00	Not reported	9.1	50.9	Not reported

C9D1: Disease Symptoms (n=9)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	19.14	Not reported	8.7	29.6	Not reported

C9D1: Side Effects of Treatment (n=9)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	19.75	Not reported	10.8	28.7	Not reported

C9D1: Future Perspective (n=9)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	39.51	Not reported	18.5	60.5	Not reported

C9D1: Body Image (n=9)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.93	Not reported	4.6	47.3	Not reported

C10D1: Disease Symptoms (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.93	Not reported	17.1	34.7	Not reported

C10D1: Side Effects of Treatment (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	18.83	Not reported	5.9	31.7	Not reported

C10D1: Future Perspective (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	33.33	Not reported	-4.3	70.9	Not reported

C10D1: Body Image (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	16.67	Not reported	-12.6	45.9	Not reported

C11D1: Disease Symptoms (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	18.52	Not reported	7.7	29.4	Not reported

C11D1: Side Effects of Treatment (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	18.52	Not reported	7.3	29.8	Not reported

C11D1: Future Perspective (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	38.89	Not reported	-4.6	82.4	Not reported

C11D1: Body Image (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	22.22	Not reported	-6.3	50.8	Not reported

C12D1: Disease Symptoms (n=5)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	28.89	Not reported	18.7	39.1	Not reported

C12D1: Side Effects of Treatment (n=5)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	24.30	Not reported	8.1	40.5	Not reported

C12D1: Future Perspective (n=5)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	53.33	Not reported	-2.2	108.9	Not reported

C12D1: Body Image (n=5)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	40.00	Not reported	-14.0	94.0	Not reported

C13D1: Disease Symptoms (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.00	Not reported	14.1	35.9	Not reported

C13D1: Side Effects of Treatment (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	18.70	Not reported	5.4	32.0	Not reported

C13D1: Future Perspective (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	37.04	Not reported	-5.8	79.8	Not reported

C13D1: Body Image (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	33.33	Not reported	2.0	64.6	Not reported

C14D1: Disease Symptoms (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	19.45	Not reported	11.4	27.5	Not reported

C14D1: Side Effects of Treatment (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	18.64	Not reported	5.3	32.0	Not reported

C14D1: Future Perspective (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	35.19	Not reported	-9.3	79.7	Not reported

C14D1: Body Image (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	16.67	Not reported	-12.6	45.9	Not reported

C15D1: Disease Symptoms (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	23.15	Not reported	6.9	39.4	Not reported

C15D1: Side Effects of Treatment (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	18.09	Not reported	8.2	28.0	Not reported

C15D1: Future Perspective (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	38.89	Not reported	-4.6	82.4	Not reported

C15D1: Body Image (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	16.67	Not reported	-12.6	45.9	Not reported

C16D1: Disease Symptoms (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	27.78	Not reported	9.3	46.2	Not reported

C16D1: Side Effects of Treatment (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	16.91	Not reported	5.0	28.9	Not reported

C16D1: Future Perspective (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	37.04	Not reported	-5.8	79.8	Not reported

C16D1: Body Image (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	22.22	Not reported	-13.9	58.4	Not reported

C17D1: Disease Symptoms (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	24.07	Not reported	11.0	37.2	Not reported

C17D1: Side Effects of Treatment (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	19.26	Not reported	5.0	33.6	Not reported

C17D1: Future Perspective (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	38.89	Not reported	-2.7	80.4	Not reported

C17D1: Body Image (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	22.22	Not reported	-6.3	50.8	Not reported

C18D1: Disease Symptoms (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	41.85	Not reported	25.9	57.8	Not reported

C18D1: Side Effects of Treatment (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	18.52	Not reported	4.8	32.2	Not reported

C18D1: Future Perspective (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	38.89	Not reported	-2.7	80.4	Not reported

C18D1: Body Image (n=6)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	33.33	Not reported	2.0	64.6	Not reported

C19D1: Disease Symptoms (n=4)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	43.06	Not reported	18.7	67.4	Not reported

C19D1: Side Effects of Treatment (n=4)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	25.74	Not reported	4.6	46.8	Not reported

C19D1: Future Perspective (n=4)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	38.89	Not reported	-29.6	107.4	Not reported

C19D1: Body Image (n=4)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	41.67	Not reported	-25.1	108.4	Not reported

C20D1: Disease Symptoms (n=2)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	44.45	Not reported	-96.8	185.7	Not reported

C20D1: Side Effects of Treatment (n=2)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	35.19	Not reported	11.6	58.8	Not reported

C20D1: Future Perspective (n=2)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	66.67	Not reported	-357	490.2	Not reported

C20D1: Body Image (n=2)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	50.00	Not reported	-162	261.8	Not reported

C21D1: Disease Symptoms (n=1)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	77.78	Not reported	NA	NA	95% CI was not estimable since only 1 participant was evaluable.

C21D1: Side Effects of Treatment (n=1)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	36.67	Not reported	NA	NA	95% CI was not estimable since only 1 participant was evaluable.

C21D1: Future Perspective (n=1)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	44.44	Not reported	NA	NA	95% CI was not estimable since only 1 participant was evaluable.

C21D1: Body Image (n=1)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	33.33	Not reported	NA	NA	95% CI was not estimable since only 1 participant was evaluable.

C22D1: Disease Symptoms (n=1)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	61.11	Not reported	NA	NA	95% CI was not estimable since only 1 participant was evaluable.

C22D1: Side Effects of Treatment (n=1)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	33.33	Not reported	NA	NA	95% CI was not estimable since only 1 participant was evaluable.

C22D1: Future Perspective (n=1)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	44.44	Not reported	NA	NA	95% CI was not estimable since only 1 participant was evaluable.

C22D1: Body Image (n=1)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	66.67	Not reported	NA	NA	95% CI was not estimable since only 1 participant was evaluable.

End of Treatment: Disease Symptoms (n=17)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	37.58	Not reported	23.5	51.7	Not reported

End of Treatment: Side Effects of Treatment (n=17)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	29.51	Not reported	21.5	37.6	Not reported

End of Treatment: Future Perspective (n=17)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	46.41	Not reported	34.4	58.4	Not reported

End of Treatment: Body Image (n=17)

Values in units on a scale · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)	29.41	Not reported	13.5	45.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
25.5
upper Limit
45.9
value
35.68
title
C1D1: Disease Symptoms (n=27)
categories
measurements
group Id
OG000
lower Limit
17.7
upper Limit
33.5
value
25.61
title
C1D1: Side Effects of Treatment (n=27)
categories
measurements
group Id
OG000
lower Limit
36.4
upper Limit
56.6
value
46.50
title
C1D1: Future Perspective (n=27)
categories
measurements
group Id
OG000
lower Limit
11.2
upper Limit
38.2
value
24.69
title
C1D1: Body Image (n=27)
categories
measurements
group Id
OG000
lower Limit
25.3
upper Limit
45.7
value
35.51
title
C1D8: Disease Symptoms (n=25)
categories
measurements
group Id
OG000
lower Limit
16.1
upper Limit
31.7
value
23.90
title
C1D8: Side Effects of Treatment (n=25)
categories
measurements
group Id
OG000
lower Limit
32.9
upper Limit
56.0
value
44.44
title
C1D8: Future Perspective (n=25)
categories
measurements
group Id
OG000
lower Limit
3.6
upper Limit
23.1
value
13.33
title
C1D8: Body Image (n=25)
categories
measurements
group Id
OG000
lower Limit
22.7
upper Limit
41.9
value
32.31
title
C1D15: Disease Symptoms (n=25)
categories
measurements
group Id
OG000
lower Limit
19.8
upper Limit
33.9
value
26.89
title
C1D15: Side Effects of Treatment (n=25)
categories
measurements
group Id
OG000
lower Limit
37.0
upper Limit
60.7
value
48.89
title
C1D15: Future Perspective (n=25)
categories
measurements
group Id
OG000
lower Limit
14.4
upper Limit
41.6
value
28.00
title
C1D15: Body Image (n=25)

denoms

counts
group Id
OG000
value
27
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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 2 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(Phase2:Schedule B)

param Type

MEAN

population Description

PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at spefied time points for each arm, respectively.

reporting Status

POSTED

time Frame

C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)

title

Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2

type

SECONDARY

unit Of Measure

units on a scale

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Preserved source evidence · Not medical advice