NCT00872521 · REGISTRY CONDITION SEARCH

A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2014-05-16

The purpose of this study is to determine efficacy of treatment with bortezomib (in combination with doxorubicin and dexamethasone) in previously untreated patients with Multiple Myeloma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction

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outcome · POSTED

Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction

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outcome · POSTED

Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).

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outcome · POSTED

Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)

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outcome · POSTED

Event Free Survival (EFS)

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outcome · POSTED

Overall Survival

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outcome · POSTED

Assessment of Quality of Life (AQoL) Scores

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outcome · POSTED

Overall Response Rate (ORR) Stratified by Protein Expression (p53)

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outcome · POSTED

Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).

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outcome · POSTED

Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2)

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outcome · POSTED

Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3)

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outcome · POSTED

Overall Survival (OS) Stratified by Protein Expression (p53).

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outcome · POSTED

Overall Survival (OS) Stratified by Protein Expression (Cyclin D1)

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outcome · POSTED

Overall Survival (OS) Stratified by Protein Expression (Bcl-2)

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outcome · POSTED

Overall Survival (OS) Stratified by Protein Expression (FGFR3)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Previously diagnosed with multiple myeloma * eligible for autologous stem cell transplantation * meets pre-treatment lab criteria (as defined within protocol). Exclusion Criteria: * Previously received treatment for multiple myeloma (including prior therapy with radiation or pulsed dexamethasone), except localised radiation to a solitary lesion or plasmacytomas or 4 days of corticosteroid therapy * have a current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), or Waldenström Macroglobulinemia * have a history of any other malignancy within 5 years before enrolment * have other significant comorbidities.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
PAD induction Open Label Treatment: Four 21-day Treatment Cycles Bortezomib 1.3 mg/m2 i.v. (D1 4 8 \& 11) Doxorubicin 20 mg/m2 i.v. (D1 \& 4) Dexamethasone 20 mg p.o. (D1 2 4 5 8 9 11 \& 12)
intervention Names
Drug: PAD induction
label
bortezomib; doxorubicin; dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
bortezomib; doxorubicin; dexamethasone
description
Open Label Treatment: Four 21-day Treatment Cycles Bortezomib 1.3 mg/m2 i.v. (D1, 4, 8 \& 11), Doxorubicin 20 mg/m2 i.v. (D1 \& 4), Dexamethasone 20 mg p.o. (D1, 2, 4, 5, 8 , 9, 11 \& 12)
name
PAD induction
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 107
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
International Myeloma Working Group (IMWG) criteria - CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and \<5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, \>90% in serum M-protein+urine, M-protein level \<100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or \<200 mg/24hour
measure
Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
time Frame
84 days

secondary Outcomes

description
Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD).
measure
Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction
time Frame
84 days
description
Responders are the number of participants who achieved stringent complete response (sCR)/ complete response (CR), very good partial response (VGPR) or partial response (PR) following PAD induction.
measure
Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).
time Frame
3-months following ASCT
description
Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria.
measure
Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)
time Frame
3-months after ASCT
description
Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
measure
Event Free Survival (EFS)
time Frame
2 years after Day 1 Cycle 1 of PAD
description
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).
measure
Overall Survival
time Frame
2 years after Day 1 Cycle 1 of PAD
description
The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL).
measure
Assessment of Quality of Life (AQoL) Scores
time Frame
Up to 2 years
description
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53).
measure
Overall Response Rate (ORR) Stratified by Protein Expression (p53)
time Frame
84 days
description
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1).
measure
Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).
time Frame
84 days
description
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2)
measure
Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2)
time Frame
84 days
description
Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3)
measure
Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3)
time Frame
84 days
description
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (p53).
measure
Overall Survival (OS) Stratified by Protein Expression (p53).
time Frame
2 years after Day 1 Cycle 1 of PAD
description
Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (Cyclin D1).
measure
Overall Survival (OS) Stratified by Protein Expression (Cyclin D1)
time Frame
2 years after Day 1 Cycle 1 of PAD

Full study description

brief Summary: The purpose of this study is to determine efficacy of treatment with bortezomib (in combination with doxorubicin and dexamethasone) in previously untreated patients with Multiple Myeloma.
detailed Description: This is an open-label, single-arm, multicentre study which will enroll approximately 105 patients. Open-label means all people involved in the study know the identity of the intervention. Single-arm means there is one group of patients, all receiving the same treatment. Four 21-day cycles of a combination of bortezomib i.v. (intravenous) 1.3 mg/m2 (Days 1, 4, 8 and 11), doxorubicin i.v. 20 mg/m2 (days 1 and 4) and dexamethasone p.o. (by mouth) (days 1, 2, 4, 5, 8, 9, 11 and 12) (PAD) will be given. Patients will be discontinued if disease progresses, or unacceptable treatment-related toxicity occurs. Following PAD treatment, patients will have peripheral blood stem cells (PBSC) collected, and an autologous stem cell transplant (ASCT) will be performed. Patients will then make monthly visits to the Study Doctor until 1 year after start of treatment, and attend a final follow-up visit at 2 years. Efficacy assessment of response to PAD will be made using the International Myeloma Working Group (IMWG) criteria. The primary outcome is to compare the overall response rate following 4 cycles of PAD induction therapy between patients with and without extra copies of the long arm of the first chromosome (1q21) measured by fluorescent in situ hybridisation (FISH) in their marrow at baseline. Patient reported outcomes will be assessed using the AQoL (Assessment of Quality of Life). Safety will be evaluated throughout the study by assessment of adverse events including changes in physical examination, concomitant medication, ECOG (Eastern Cooperative Oncology Group) scores, vital signs and clinical laboratory findings. A sample size of 105 provides 80% power (a=0.05) to detect a difference in overall response rate of 28% at the end of 4 cycles of PAD. This is based on the assumptions that 44% of patients have amplification of 1q21 1, 2, the overall response rate with PAD combination therapy is 80%; the overall response rate with PAD if PAD therapy does not overcome 1q21 amplification is assumed to be 64%, while without 1q21 amplification it is assumed to be 92%. That is: Overall Response Rate (ORR) = P1q21 amplified x ORRamplified + P1q21 not amplified x ORRnot amplified i.e. 80% = 44% x 64% + 56% x 92%. The sample size of 105 allows for a 20% drop-out rate. Four 21-day cycles of PAD: a combination of bortezomib i.v. (intravenous) 1.3 mg/m2 (Days 1, 4, 8 and 11), doxorubicin i.v. 20 mg/m2 (days 1 and 4) and dexamethasone p.o. (by mouth) (days 1, 2, 4, 5, 8, 9, 11 and 12).

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice