Refractory Multiple MyelomaPhase 3NCT00217438
Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma
A Phase 3 study testing melphalan, amifostine trihydrate and peripheral blood stem cell transplantation in people with Refractory Multiple Myeloma and Stage II Multiple Myeloma, run by Fred Hutchinson Cancer Center at 4 sites in United States.
Trial summary
RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- What is being tested?
- melphalan, amifostine trihydrate and peripheral blood stem cell transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2005to Oct 2012
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have MM undergoing autologous or syngeneic hematopoietic transplantation
- Patients must meet Salmon and Durie criteria for initial diagnosis of MM
- Transplant will be offered to patients with stage II or III MM
- Measurable disease, defined as serum monoclonal protein >= 0.2 g/dl or Bence Jones protein >= 200 mg/24 h
- Karnofsky >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectancy is not severely limited by concomitant illness
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- Left ventricular ejection fraction >= 50%
- No uncontrolled arrhythmias or symptomatic cardiac disease
- Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusion capacity of carbon monoxide (DLCO) >= 50%
- No symptomatic pulmonary disease
- Human immunodeficiency virus (HIV) negative
- Bilirubin < 2 mg/dl
- Serum glutamic pyruvate transaminase (SGPT) < 2.5 x normal
- Creatinine clearance >= 60 cc/min, estimated or measured
- Signed informed consent
Who cannot join
- Pregnant or lactating females
- Uncontrolled infection
- Planned tandem autologous/reduced intensity allograft
- Insufficient PBSC for an autologous transplant (< 3.0 x 10^6 CD34+ cells/kg total)
- Prior autologous transplant
- Non-secretory myeloma and patients who are in a complete response or near complete response after conventional therapy
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- Patients unwilling to practice adequate forms of contraception if clinically indicated
- Male patients on study need to be consulted to use latex condoms, even if they have had a vasectomy, every time they have sex with a woman who is able to have children
- Patients with history of seizures
- Patients receiving antihypertensive therapy that cannot be stopped for 24 hours preceding amifostine treatment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Rochester
Rochester, New York, 14642
VA Puget Sound Health Care System
Seattle, Washington, 98101
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Multi-Center Phase III Study of Autologous Transplantation for Patients With Multiple Myeloma Comparing Melphalan 280 mg/m2 + Amifostine With Melphalan 200 mg/m2 + Amifostine
RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using stem cells from the patient or an identical brother or sister, may allow more chemotherapy to be given so more cancer cells are killed. Giving maintenance therapy after a stem cell transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan is more effective in treating multiple myeloma (MM).
PURPOSE: This randomized phase III trial is studying two different doses of melphalan to compare how well they work when given together with amifostine followed by one or two autologous or syngeneic stem cell transplants and maintenance therapy in treating patients with stage II-III MM
Read the detailed description
PRIMARY OBJECTIVES:
- Compare the complete response (CR) and near CR rate in patients undergoing autologous stem cell transplant (ASCT) using melphalan 280 mg/m^2 or melphalan 200 mg/m^2.
SECONDARY OBJECTIVES:
- Compare toxicities between patients receiving amifostine and melphalan 280 mg/m^2 or melphalan 200 mg/m^2.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
INDUCTION THERAPY:
ARM I (HIGH DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine intravenously (IV) over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.
ARM II (LOW DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.
AUTOLOGOUS OR SYNGENEIC PERIPHERAL BLOOD STEM CELL TRANSPLANTATION (PBSCT): At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
After completion of study treatment, patients are followed up every 3 months for 5 years.
- Being tested
- melphalan, amifostine trihydrate, peripheral blood stem cell transplantation, fluorescence in situ hybridization, bone marrow ablation with stem cell support
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melphalanDrug
Also called Alkeran, CB-3025, L-PAM, L-phenylalanine mustard
Given IV
amifostine trihydrateDrug
Also called ethiofos, Ethyol, gammaphos, WR-2721
Given IV
peripheral blood stem cell transplantationProcedure or surgery
Also called PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Undergo PBSCT
fluorescence in situ hybridizationGenetic
Also called fluorescence in situ hybridization (FISH)
Correlative study
bone marrow ablation with stem cell supportProcedure or surgery
Undergo transplant
| Study group | Role | What they receive |
|---|---|---|
| Arm I (high dose melphalan, amifostine trihydrate, transplant) | Experimental | INDUCTION THERAPY:
Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy. Receives: Drug: melphalan; Drug: amifostine trihydrate; Procedure: peripheral blood stem cell transplantation; Genetic: fluorescence in situ hybridization; Procedure: bone marrow ablation with stem cell support |
| Arm II (low dose melphalan, amifostine trihydrate, transplant) | Active comparator | INDUCTION THERAPY:
Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.
AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy. Receives: Drug: melphalan; Drug: amifostine trihydrate; Procedure: peripheral blood stem cell transplantation; Genetic: fluorescence in situ hybridization; Procedure: bone marrow ablation with stem cell support |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR and Near CR Rates
Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. "Near" Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey.
Measured: Up to 120 days after transplant
Secondary outcomes (1)
Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2
Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Measured: Up to day 56 after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionOct 2012
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 Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William Bensinger, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217438
- Sponsor's protocol ID
- 2004.00
- Other IDs
- NCI-2009-01543
- Status last verified
- Aug 2015
- First submitted
- 20 Sep 2005
- Last updated
- 21 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Phase III Study of Autologous Transplantation for Patients With Multiple Myeloma Comparing Melphalan 280 mg/m2 + Amifostine With Melphalan 200 mg/m2 + Amifostine
- ClinicalTrials.gov ID
- NCT00217438
- Acronym / sponsor ID
- 2004.00
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2005
- Primary completion
- Oct 2012 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 19 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using stem cells from the patient or an identical brother or sister, may allow more chemotherapy to be given so more cancer cells are killed. Giving maintenance therapy after a stem cell transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan is more effective in treating multiple myeloma (MM).
PURPOSE: This randomized phase III trial is studying two different doses of melphalan to compare how well they work when given together with amifostine followed by one or two autologous or syngeneic stem cell transplants and maintenance therapy in treating patients with stage II-III MM
Detailed description
PRIMARY OBJECTIVES:
- Compare the complete response (CR) and near CR rate in patients undergoing autologous stem cell transplant (ASCT) using melphalan 280 mg/m^2 or melphalan 200 mg/m^2.
SECONDARY OBJECTIVES:
- Compare toxicities between patients receiving amifostine and melphalan 280 mg/m^2 or melphalan 200 mg/m^2.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
INDUCTION THERAPY:
ARM I (HIGH DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine intravenously (IV) over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.
ARM II (LOW DOSE MELPHALAN AND AMIFOSTINE): Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.
AUTOLOGOUS OR SYNGENEIC PERIPHERAL BLOOD STEM CELL TRANSPLANTATION (PBSCT): At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.
Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.
Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
After completion of study treatment, patients are followed up every 3 months for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (high dose melphalan, amifostine trihydrate, transplant) | Experimental | Drug: melphalan, Drug: amifostine trihydrate, Procedure: peripheral blood stem cell transplantation, Genetic: fluorescence in situ hybridization, Procedure: bone marrow ablation with stem cell supportINDUCTION THERAPY: Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy. |
| Arm II (low dose melphalan, amifostine trihydrate, transplant) | Active comparator | Drug: melphalan, Drug: amifostine trihydrate, Procedure: peripheral blood stem cell transplantation, Genetic: fluorescence in situ hybridization, Procedure: bone marrow ablation with stem cell supportINDUCTION THERAPY: Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients who have MM undergoing autologous or syngeneic hematopoietic transplantation
- Patients must meet Salmon and Durie criteria for initial diagnosis of MM
- Transplant will be offered to patients with stage II or III MM
- Measurable disease, defined as serum monoclonal protein >= 0.2 g/dl or Bence Jones protein >= 200 mg/24 h
- Karnofsky >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
Key exclusion criteria (10 listed)
- Pregnant or lactating females
- Uncontrolled infection
- Planned tandem autologous/reduced intensity allograft
- Insufficient PBSC for an autologous transplant (< 3.0 x 10^6 CD34+ cells/kg total)
- Prior autologous transplant
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 |
|---|---|---|
| melphalanAlso: Alkeran, CB-3025, L-PAM, L-phenylalanine mustardGiven IV | Drug | Arm I (high dose melphalan, amifostine trihydrate, transplant), Arm II (low dose melphalan, amifostine trihydrate, transplant) |
| amifostine trihydrateAlso: ethiofos, Ethyol, gammaphos, WR-2721Given IV | Drug | Arm I (high dose melphalan, amifostine trihydrate, transplant), Arm II (low dose melphalan, amifostine trihydrate, transplant) |
| peripheral blood stem cell transplantationAlso: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cellUndergo PBSCT | Procedure or surgery | Arm I (high dose melphalan, amifostine trihydrate, transplant), Arm II (low dose melphalan, amifostine trihydrate, transplant) |
| fluorescence in situ hybridizationAlso: fluorescence in situ hybridization (FISH)Correlative study | Genetic | Arm I (high dose melphalan, amifostine trihydrate, transplant), Arm II (low dose melphalan, amifostine trihydrate, transplant) |
| bone marrow ablation with stem cell supportUndergo transplant | Procedure or surgery | Arm I (high dose melphalan, amifostine trihydrate, transplant), Arm II (low dose melphalan, amifostine trihydrate, transplant) |
Primary outcome
CR and Near CR Rates
Time frame: Up to 120 days after transplant
Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. "Near" Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey.
1 secondary outcome
Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2
Time frame: Up to day 56 after transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- 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.
William Bensinger principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing melphalan, amifostine trihydrate and peripheral blood stem cell transplantation in people with Refractory Multiple Myeloma and Stage II Multiple Myeloma, run by Fred Hutchinson Cancer Center at 4 sites 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 10 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 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Sep 2014). 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?
CR and Near CR Rates (time frame: Up to 120 days after transplant). 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 21 Aug 2015.