Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00792142
Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma
A Phase 2 study testing bortezomib, dexamethasone and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm and Neurotoxicity, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm, Neurotoxicity
- What is being tested?
- bortezomib, dexamethasone and melphalan
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2008to 21 Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Multiple Myeloma patients with symptomatic disease, stage II or III at diagnosis or progressive stage I requiring chemotherapy and/or radiation therapy (by Salmon-Durie classification), who are not eligible for tandem transplant study using TMI; because of previous radiation or eligibility criteria; documentation of disease staging by both Salmon-Durie classification and International Staging System (ISS) is required
- Patients with non-secretory myeloma should have measurable serum free-light chain protein by the Free-lite test or measurable disease such as a soft tissue myeloma
- A minimum of 4 x 10^6 of CD 34 Positive cell/kg has been harvested
- A Karnofsky performance status (KPS) of >= 70% is required unless the KPS is impaired due to bone disease
- No contraindication to the collection of a minimum of 4 x 10^6 CD34+ cells/kg by apheresis
- All patients must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
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- Bilirubin =< 1.5 mg/dl
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) < 2.5 x upper limits of normal
- Creatinine clearance of >= 40cc/min
- Absolute neutrophil count of > 1000/ul
- Platelet count of > 100,000/ul
- Cardiac ejection fraction >= 45% by multigated acquisition (MUGA) scan and/or by echocardiogram
- Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted lower limit
- Human immunodeficiency virus (HIV) antibody tests negative
- No other medical, or psychosocial problems which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimen
Who cannot join
- Presence of peripheral neuropathy >= grade II
- Patients with evidence of disease progression (with >= 25% increase in M protein) on bortezomib and or thalidomide therapy prior to transplant
- Pregnant or nursing women, as well as women of child bearing age, who are unwilling to use a dual method of contraception and men who are unwilling to use condom
- Patients with history of hypersensitivity to bortezomib, boron or mannitol
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010-3000
About this study
Official title: A Phase II Study of Maintenance Treatment With Sequential Bortezomib, Thalidomide and Dexamethasone Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Multiple Myeloma
RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with thalidomide and dexamethasone may kill any cancer cells that remain after high-dose melphalan and stem cell transplant in patients with multiple myeloma.
PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with thalidomide and dexamethasone after melphalan and stem cell transplant and to see how well it works in treating patients with stage I-III multiple myeloma.
Read the detailed description
OBJECTIVES:
Primary
- To assess the feasibility and toxicities of maintenance therapy with sequential bortezomib, thalidomide, and dexamethasone after high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
- To assess whether administration of sequential bortezomib, thalidomide, and dexamethasone can improve progression-free survival of these patients.
Secondary
- To assess whether administration of sequential bortezomib, thalidomide, and dexamethasone can increase complete remission rate and duration of response in these patients.
- To assess the impact of maintenance therapy with sequential bortezomib, thalidomide, and dexamethasone after transplantation on overall survival of these patients.
- To evaluate the influence of cytogenetic abnormalities (e.g., chromosome 13 deletion, 14 q32 abnormality, t [4;14], chromosome 1 q21 amplification, and chromosome 17 deletion) on outcome by performing conventional cytogenetic study and fluorescence in situ hybridization (FISH) studies on baseline and post-transplant bone marrow specimens.
OUTLINE:
- High-dose melphalan and autologous peripheral blood stem cell transplantation (PBSCT): Patients receive high-dose melphalan IV over 30 minutes on days -2 and -1 and undergo autologous PBSCT on day 0. Patients receive filgrastim (G-CSF) IV or subcutaneously beginning on day 5 and continuing until blood counts recover.
- Maintenance therapy: Beginning 4-8 weeks after transplantation, patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone on days 1-4; treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive oral thalidomide once daily until disease progression.
Patients complete the FACT-GOG neurotoxicity questionnaire periodically. Bone marrow samples are collected at baseline and post-transplant for cytogenetic analysis by FISH.
- Being tested
- bortezomib, dexamethasone, melphalan, thalidomide, cytogenetic analysis
- Keywords
- neurotoxicity, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Given IV
dexamethasoneDrug
Given orally
melphalanDrug
Given IV
thalidomideDrug
Given orally
cytogenetic analysisGenetic
Performed on baseline and post transplant bone marrow specimens
fluorescence in situ hybridizationGenetic
Performed on baseline and post transplant bone marrow specimens
laboratory biomarker analysisOther
Baseline, post transplant and prior to start of bortezomib, every 3 months post transplant for the first year, after 6 cycles of bortezomib, every year after transplant for 2-4 years.
questionnaire administrationOther
Completed at baseline (within 6 weeks prior to enrollment) and at 2 months post transplant and once a month after that for the first year. For the second year the questionnaire will be completed every 3 months as long as on thalidomide for the duration of the study.
autologous hematopoietic stem cell transplantationProcedure or surgery
Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan
peripheral blood stem cell transplantationProcedure or surgery
Minimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan
| Study group | Role | What they receive |
|---|---|---|
| Treatment (stem cell transplant, maintenance treatment) | Experimental | Patients receive high-dose melphalan IV over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation on day 0. Patients receive filgrastim IV or SC beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive oral thalidomide once daily until disease progression. Receives: Drug: bortezomib; Drug: dexamethasone; Drug: melphalan; Drug: thalidomide; Genetic: cytogenetic analysis; Genetic: fluorescence in situ hybridization; Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: autologous hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
All grade 3 and above treatment-related adverse events (AEs) during bortezomib/dexamethasone treatment cycles.
Measured: After 4 months of maintenance therapy
One Year Overall Survival
One year overall survival estimated using the product-limit method of Kaplan and Meier. Defined as the percentage of patients alive at year one after starting treatment.
Measured: From date of treatment initiation until death from any cause, assessed up to one year.
Secondary outcomes (2)
Count of Response in Patients Started on Maintenance Therapy
Complete Response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.
Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100mg per 24-h.
Partial Response (PR): > 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by > 90% or to < 200mg per 24-h In addition to the above listed criteria, if present at baseline, a . 50% reduction in the size of soft tissue plasmacytomas is also required.
Stable Disease (SD): Not meeting criteria for CR, VGPR, PR or progressive disease.
Relapse: Any of the following: Reappearance of serum or urine M-protein by immunofixation or electrophoresis Development of > 5% plasma cells in the bone marrow. Appearance of any other sign of progression (i.e., new plasmacytoma, lytic bone lesion)
Measured: Post-Thalidomide at 1 year.
One Year Progression-free Survival (PFS)
PFS estimated using the product-limit method of Kaplan and Meier. Defined as the percentage of patients progression-free at year one after starting treatment.
International Myeloma Working Group uniform response criteria for disease progression:
Increase of > 25% from baseline in Serum M-component and/or (the absolute increase must be > 0.5 g/dl); Urine M-component and/or (the absolute increase must be > 200 mg/24 h; Only in patients without measurable serum and urine M-protein levels:
the difference between involved and uninvolved FLC levels. The absolute increase must be >l0mg/dl.
Bone marrow plasma cell percentage: the absolute % must be > 10%C; Definite development of new bone lesions or soft tissue plasmacytomas.
or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum calcium >11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder.
Measured: From start of treatment initiation until disease progression, relapse or death from any cause, assessed up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study start16 Jan 2008
- Primary completion21 Apr 2014
- Study completion21 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Firoozeh Sahebi, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792142
- Sponsor's protocol ID
- 06143
- Other IDs
- P30CA033572, CHNMC-06143, MILLENNIUM-06143, CDR0000624513
- Status last verified
- Jan 2020
- First submitted
- 14 Nov 2008
- Last updated
- 19 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Maintenance Treatment With Sequential Bortezomib, Thalidomide and Dexamethasone Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00792142
- Acronym / sponsor ID
- 06143
- Keywords
- neurotoxicity, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Jan 2008
- Primary completion
- 21 Apr 2014 (actual)
- Study completion
- 21 Apr 2014 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Posted 17 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Bortezomib and thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Bortezomib may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with thalidomide and dexamethasone may kill any cancer cells that remain after high-dose melphalan and stem cell transplant in patients with multiple myeloma.
PURPOSE: This phase II trial is studying the side effects of giving bortezomib together with thalidomide and dexamethasone after melphalan and stem cell transplant and to see how well it works in treating patients with stage I-III multiple myeloma.
Detailed description
OBJECTIVES:
Primary
- To assess the feasibility and toxicities of maintenance therapy with sequential bortezomib, thalidomide, and dexamethasone after high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
- To assess whether administration of sequential bortezomib, thalidomide, and dexamethasone can improve progression-free survival of these patients.
Secondary
- To assess whether administration of sequential bortezomib, thalidomide, and dexamethasone can increase complete remission rate and duration of response in these patients.
- To assess the impact of maintenance therapy with sequential bortezomib, thalidomide, and dexamethasone after transplantation on overall survival of these patients.
- To evaluate the influence of cytogenetic abnormalities (e.g., chromosome 13 deletion, 14 q32 abnormality, t [4;14], chromosome 1 q21 amplification, and chromosome 17 deletion) on outcome by performing conventional cytogenetic study and fluorescence in situ hybridization (FISH) studies on baseline and post-transplant bone marrow specimens.
OUTLINE:
- High-dose melphalan and autologous peripheral blood stem cell transplantation (PBSCT): Patients receive high-dose melphalan IV over 30 minutes on days -2 and -1 and undergo autologous PBSCT on day 0. Patients receive filgrastim (G-CSF) IV or subcutaneously beginning on day 5 and continuing until blood counts recover.
- Maintenance therapy: Beginning 4-8 weeks after transplantation, patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone on days 1-4; treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive oral thalidomide once daily until disease progression.
Patients complete the FACT-GOG neurotoxicity questionnaire periodically. Bone marrow samples are collected at baseline and post-transplant for cytogenetic analysis by FISH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (stem cell transplant, maintenance treatment) | Experimental | Drug: bortezomib, Drug: dexamethasone, Drug: melphalan, Drug: thalidomide, Genetic: cytogenetic analysis, Genetic: fluorescence in situ hybridization, Other: laboratory biomarker analysis, Other: questionnaire administration, Procedure: autologous hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantationPatients receive high-dose melphalan IV over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation on day 0. Patients receive filgrastim IV or SC beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive oral thalidomide once daily until disease progression. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Multiple Myeloma patients with symptomatic disease, stage II or III at diagnosis or progressive stage I requiring chemotherapy and/or radiation therapy (by Salmon-Durie classification), who are not eligible for tandem transplant study using TMI; because of previous radiation or eligibility criteria; documentation of disease staging by both Salmon-Durie classification and International Staging System (ISS) is required
- Patients with non-secretory myeloma should have measurable serum free-light chain protein by the Free-lite test or measurable disease such as a soft tissue myeloma
- A minimum of 4 x 10^6 of CD 34 Positive cell/kg has been harvested
- A Karnofsky performance status (KPS) of >= 70% is required unless the KPS is impaired due to bone disease
- No contraindication to the collection of a minimum of 4 x 10^6 CD34+ cells/kg by apheresis
Key exclusion criteria (4 listed)
- Presence of peripheral neuropathy >= grade II
- Patients with evidence of disease progression (with >= 25% increase in M protein) on bortezomib and or thalidomide therapy prior to transplant
- Pregnant or nursing women, as well as women of child bearing age, who are unwilling to use a dual method of contraception and men who are unwilling to use condom
- Patients with history of hypersensitivity to bortezomib, boron or mannitol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomibGiven IV | Drug | Treatment (stem cell transplant, maintenance treatment) |
| dexamethasoneGiven orally | Drug | Treatment (stem cell transplant, maintenance treatment) |
| melphalanGiven IV | Drug | Treatment (stem cell transplant, maintenance treatment) |
| thalidomideGiven orally | Drug | Treatment (stem cell transplant, maintenance treatment) |
| cytogenetic analysisPerformed on baseline and post transplant bone marrow specimens | Genetic | Treatment (stem cell transplant, maintenance treatment) |
| fluorescence in situ hybridizationPerformed on baseline and post transplant bone marrow specimens | Genetic | Treatment (stem cell transplant, maintenance treatment) |
| laboratory biomarker analysisBaseline, post transplant and prior to start of bortezomib, every 3 months post transplant for the first year, after 6 cycles of bortezomib, every year after transplant for 2-4 years. | Other | Treatment (stem cell transplant, maintenance treatment) |
| questionnaire administrationCompleted at baseline (within 6 weeks prior to enrollment) and at 2 months post transplant and once a month after that for the first year. For the second year the questionnaire will be completed every 3 months as long as on thalidomide for the duration of the study. | Other | Treatment (stem cell transplant, maintenance treatment) |
| autologous hematopoietic stem cell transplantationMinimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan | Procedure or surgery | Treatment (stem cell transplant, maintenance treatment) |
| peripheral blood stem cell transplantationMinimum dose of 2 X 10(6) CD34 + cells/kg day 0 after two days of treatment with Melphalan | Procedure or surgery | Treatment (stem cell transplant, maintenance treatment) |
Primary outcome
Number of Participants With Adverse Events
Time frame: After 4 months of maintenance therapy
All grade 3 and above treatment-related adverse events (AEs) during bortezomib/dexamethasone treatment cycles.
One Year Overall Survival
Time frame: From date of treatment initiation until death from any cause, assessed up to one year.
One year overall survival estimated using the product-limit method of Kaplan and Meier. Defined as the percentage of patients alive at year one after starting treatment.
2 secondary outcomes
Count of Response in Patients Started on Maintenance Therapy
Time frame: Post-Thalidomide at 1 year.
One Year Progression-free Survival (PFS)
Time frame: From start of treatment initiation until disease progression, relapse or death from any cause, assessed up to 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Firoozeh Sahebi, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib, dexamethasone and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm and Neurotoxicity, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: After 4 months of maintenance therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.