Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00003146
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
A Phase 2 study testing busulfan, melphalan and thiotepa in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. 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
- What is being tested?
- busulfan, melphalan and thiotepa
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Jun 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS: Histologically diagnosed stage II/III multiple myeloma (or have greater than normal beta-2-microglobulin) meeting the Salmon and Durie criteria Stage I multiple myeloma must have had prior chemotherapy before undergoing transplantation
PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine clearance at least 50 mg/min Cardiovascular: Left ventricular ejection fraction at least 41% Other: Not pregnant HIV negative
PRIOR CONCURRENT THERAPY: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A Phase II Trial of Thiotepa, Busulfan, and Melphalan Followed by Autologous or Syngeneic Marrow or Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with multiple myeloma.
Read the detailed description
OBJECTIVES: I. Assess the toxicity and efficacy at the maximum tolerated dose of busulfan, melphalan, and thiotepa in patients with multiple myeloma.
OUTLINE: This is a single arm, open label study. Peripheral blood stem cells (PBSC) are collected and cryopreserved, or bone marrow is harvested and stored, until infusion on day 0. Patients receive oral busulfan every 6 hours on days -8, -7, and -6. Melphalan is administered by continuous IV infusion over 30 minutes on days -5 and -4. Thiotepa is administered by continuous IV infusion over 2 hours on days -3 and -2. Patients undergo PBSC or bone marrow infusion 36-48 hours following the completion of chemotherapy (day 0). Patients are followed for 100 days posttransplant and every 3 months thereafter.
PROJECTED ACCRUAL: 30 patients will be accrued.
- Being tested
- busulfan, melphalan, thiotepa, bone marrow transplantation, peripheral blood stem cell transplantation
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
busulfanDrug
melphalanDrug
thiotepaDrug
bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2004 (estimated)
- Study startNov 1997
- Primary completionJun 2001
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- William I. Bensinger, MD, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003146
- Sponsor's protocol ID
- 1204.00
- Other IDs
- FHCRC-1204.00, NCI-H97-0007, CDR0000065929
- Status last verified
- Jun 2011
- First submitted
- 1 Nov 1999
- Last updated
- 23 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Thiotepa, Busulfan, and Melphalan Followed by Autologous or Syngeneic Marrow or Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00003146
- Acronym / sponsor ID
- 1204.00
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 1997
- Primary completion
- Jun 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 23 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with multiple myeloma.
Detailed description
OBJECTIVES: I. Assess the toxicity and efficacy at the maximum tolerated dose of busulfan, melphalan, and thiotepa in patients with multiple myeloma.
OUTLINE: This is a single arm, open label study. Peripheral blood stem cells (PBSC) are collected and cryopreserved, or bone marrow is harvested and stored, until infusion on day 0. Patients receive oral busulfan every 6 hours on days -8, -7, and -6. Melphalan is administered by continuous IV infusion over 30 minutes on days -5 and -4. Thiotepa is administered by continuous IV infusion over 2 hours on days -3 and -2. Patients undergo PBSC or bone marrow infusion 36-48 hours following the completion of chemotherapy (day 0). Patients are followed for 100 days posttransplant and every 3 months thereafter.
PROJECTED ACCRUAL: 30 patients will be accrued.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| busulfan | Drug | – |
| melphalan | Drug | – |
| thiotepa | Drug | – |
| bone marrow transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
Related trials for Multiple Myeloma and Plasma Cell Neoplasm
RecruitingObservational study
Family Study of Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
RecruitingPhase 1
ELEVATE-MM: Elotuzumab, Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
Myeloma, Multiple Myeloma
Not yet recruiting
A Randomized Controlled Trial of a Wearable Core Body Temperature Sensor Versus Standard Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Patients Undergoing CAR T-Cell Therapy in an Outpatient Setting
Myeloma
RecruitingObservational study
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
Graft-versus-leukemia, Graft vs Host Disease
Not yet recruiting
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Cardiotoxicity, Cancer
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 I. Bensinger, MD study chair
Fred Hutchinson Cancer 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 busulfan, melphalan and thiotepa in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Fred Hutchinson Cancer 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?
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 23 Jun 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 23 Jun 2011.