Multiple MyelomaPhase 2/3NCT00998270
Autologous Bone Marrow Transplantation (BMT) Compared With Allogeneic BMT in Multiple Myeloma
A Phase 2/3 study testing Autologous bone marrow transplantation and Allogeneic bone marrow transplantation in people with Multiple Myeloma, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
A prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Autologous bone marrow transplantation and Allogeneic bone marrow transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteIran
- Study dates
- Oct 2009to Oct 2017
- Phase
- Phase 2/3
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age at diagnosis equal or under 55 year
- Meeting the Durie and Salmon criteria for initial diagnosis of MM
- Stage II or III MM at diagnosis or anytime thereafter
- Symptomatic MM requiring treatment at diagnosis or anytime thereafter
- If receiving chemotherapy-based mobilization regimens, must be able to receive high-dose melphalan between 2 and 8 weeks after the initiation of mobilization therapy whether delivered at the transplant center or at a referring center
- Adequate organ function as measured by:
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- Cardiac: Left ventricular ejection fraction at rest greater than 40%
- Hepatic: Bilirubin less than 2 times the upper limit of normal and ALT and AST less than 3 times the upper limit of normal
- Renal: Creatinine clearance greater than 40 ml/min (measured or calculated/estimated)
- Pulmonary: DLCO, FEV1, and FVC greater than 50% of predicted value (corrected for hemoglobin), or O2 saturation greater than 92% of room air
- An adequate autologous graft defined as a cryopreserved PBSC graft containing at least 4.0 x 10^6 CD34+ cells/kg patient weight; if prior to enrollment it is known that a patient will be on the auto-allo arm (i.e., a consenting, eligible HLA-matched sibling donor is available), the required autograft must contain at least 2.0 x 10^6 CD34+ cells/kg patient weight; the graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells; the graft can be collected at the transplanting institution or by a referring center; for patients without an HLA-matched sibling donor, the autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight
Who cannot join
- Never advanced beyond Stage I MM since diagnosis
- Non-secretory MM (absence of a monoclonal protein [M protein] in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques)
- Plasma cell leukemia
- Karnofsky performance score less than 70%, unless approved by the Medical Monitor or one of the Protocol Chairs
- Uncontrolled hypertension
- Uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms)
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- Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or one of the Protocol Chairs; cancer treated with curative intent more than 5 years previously will be allowed
- Pregnant or breastfeeding
- Seropositive for the human immunodeficiency virus (HIV)
- Unwilling to use contraceptive techniques during and for 12 months following treatment
- Prior allograft or prior autograft
- Received mid-intensity melphalan (more than 50 mg IV) as part of prior therapy
- Prior organ transplant requiring immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province
Ardeshir Ghavamzadeh, MD, 84902635 ext. +98-21, ghavamza@sina.tums.ac.ir
Ardeshir Ghavamzadeh, MD
About this study
Official title: A Prospective, Randomized Trial of Autologous Bone Marrow Transplantation Compare With Allogeneic Bone Marrow Transplantation in Multiple Myeloma
A prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Autologous bone marrow transplantation, Allogeneic bone marrow transplantation
- Keywords
- MM
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow transplantationProcedure or surgery
Also called Autologous
Autologous transplantation:
- Endoxan (for mobilization) Dose: 2.5 g/m2 IV Time: -11 Duration: 1 day
- G-CSF (Neupogen) Dose: 0.5 micg/kg subcutaneous Time: -6 to -3 Duration: 4 days
- Melphalan Dose: 100 mg/m2 IV Time: -2 and -1 Duration: 2 days
Allogeneic bone marrow transplantationProcedure or surgery
Also called Allogeneic
Allogeneic
- Melphalan Dose: 70 mg/m2 IV Time: Duration: 2 days
- Fludarabine Dose: 30 mg/m2 IV Time: Duration: 5 days
| Study group | Role | What they receive |
|---|---|---|
| Autologous arm | Active comparator | Not described Receives: Procedure: Autologous bone marrow transplantation |
| Allogeneic arm | Experimental | Not described Receives: Procedure: Allogeneic bone marrow transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival and Progressive Free Survival in both two arms
Measured: 1 year
Secondary outcomes (3)
Overall Survival and Progressive Free Survival in both two arms
Measured: 3 year
Treatment Related Mortality (TRM) in both two arms
Measured: 3 year
Acute and Chronic GVHD in Allogeneic arm
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2014 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ardeshir Ghavamzadeh, MD, Principal investigator, Hematology-Oncology and SCT Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998270
- Sponsor's protocol ID
- HORCSCT-0901
- Status last verified
- May 2012
- First submitted
- 17 Oct 2009
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial of Autologous Bone Marrow Transplantation Compare With Allogeneic Bone Marrow Transplantation in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00998270
- Acronym / sponsor ID
- HORCSCT-0901
- Conditions
- Multiple Myeloma
- Keywords
- MM
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 20 Oct 2009 (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.
A prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous arm | Active comparator | Procedure: Autologous bone marrow transplantation |
| Allogeneic arm | Experimental | Procedure: Allogeneic bone marrow transplantation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age at diagnosis equal or under 55 year
- Meeting the Durie and Salmon criteria for initial diagnosis of MM
- Stage II or III MM at diagnosis or anytime thereafter
- Symptomatic MM requiring treatment at diagnosis or anytime thereafter
- If receiving chemotherapy-based mobilization regimens, must be able to receive high-dose melphalan between 2 and 8 weeks after the initiation of mobilization therapy whether delivered at the transplant center or at a referring center
Key exclusion criteria (13 listed)
- Never advanced beyond Stage I MM since diagnosis
- Non-secretory MM (absence of a monoclonal protein [M protein] in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques)
- Plasma cell leukemia
- Karnofsky performance score less than 70%, unless approved by the Medical Monitor or one of the Protocol Chairs
- Uncontrolled hypertension
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 |
|---|---|---|
| Autologous bone marrow transplantationAlso: AutologousAutologous transplantation: * Endoxan (for mobilization) Dose: 2.5 g/m2 IV Time: -11 Duration: 1 day * G-CSF (Neupogen) Dose: 0.5 micg/kg subcutaneous Time: -6 to -3 Duration: 4 days * Melphalan Dose: 100 mg/m2 IV Time: -2 and -1 Duration: 2 days | Procedure or surgery | Autologous arm |
| Allogeneic bone marrow transplantationAlso: AllogeneicAllogeneic * Melphalan Dose: 70 mg/m2 IV Time: Duration: 2 days * Fludarabine Dose: 30 mg/m2 IV Time: Duration: 5 days | Procedure or surgery | Allogeneic arm |
Primary outcome
Overall Survival and Progressive Free Survival in both two arms
Time frame: 1 year
3 secondary outcomes
Overall Survival and Progressive Free Survival in both two arms
Time frame: 3 year
Treatment Related Mortality (TRM) in both two arms
Time frame: 3 year
Acute and Chronic GVHD in Allogeneic arm
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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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.
Ardeshir Ghavamzadeh, MD principal investigator
Hematology-Oncology and SCT Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous bone marrow transplantation and Allogeneic bone marrow transplantation in people with Multiple Myeloma, run by Tehran University of Medical Sciences at 1 site in Iran.
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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 4 Jun 2012. 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 Iran. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ardeshir Ghavamzadeh, MD (84902635 ext. +98-21, ghavamza@sina.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival and Progressive Free Survival in both two arms (time frame: 1 year). 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 4 Jun 2012.