Multiple MyelomaPhase 2NCT01343368
Preservation of Ovarian Function After Hematopoietic Cell Transplant
A Phase 2 study testing Leuprolide, hematopoietic cell transplant and reduced intensity allogeneic HCT in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Disease
- What is being tested?
- Leuprolide, hematopoietic cell transplant and reduced intensity allogeneic HCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2015
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Interventional Arm:
- Eligible for myeloablative allogenic or autologous hematopoietic cell transplant (HCT)
- Post-menarchal female < or = 50 years of age
- Normal antimullerian hormone (AMH) level and/or follicle stimulating hormone (FSH)/leuprolide (LH) levels for age/stage of puberty
- Those women who have an FSH > 40 IU/L and whose diagnosis of malignancy and whose chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.
- Observational Arm:
Show all 10Show fewer
- Eligible for reduced intensity allogeneic HCT
- Post-menarchal female ≤ 50 years of age
- Normal AMH level and/or FSH/LH for age/stage of puberty
- Those women who an FSH >40 IU/L and whose diagnosis of malignancy and chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.
Who cannot join
- All Arms:
- History of ovarian cancer
- Surgical resection of one or both ovaries. Prior hysterectomy is allowed as long as the ovaries are intact.
- Use of GnRH agonist in last 12 months will exclude patients if lab results are not available to demonstrate adequate ovarian function prior to initiation of GnRH therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)
Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.
Read the detailed description
This study is to use gonadotropin releasing hormone (GnRH) agonist leuprolide prior myeloablative hematopoietic cell transplantation to prevent ovarian dysfunction in post-menarchal women.
The primary objective is to determine the effect of GnRH agonists on the incidence of ovarian failure.
The secondary objectives are
- to determine how effective GnRH agonists are at suppressing menses during
- to determine the incidence and timing of resumption of menstrual cycles after HCT
- to determine the incidence and timing of resumption of normal FSH and LH levels after HCT
- to determine the incidence of normal AMH levels after HCT
- to determine the effect of GnRH agonists on immune reconstitution after HCT
- to assess the safety and tolerability of GnRH agonists in the context of HCT
A total of 47 patients will be accrued in this study.
- Conditions
- Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Disease, Acute Myeloid Leukemia, Myeloproliferative Disorders
- Being tested
- Leuprolide, hematopoietic cell transplant, reduced intensity allogeneic HCT
- Keywords
- Post-menarchal
- Medical subject headings
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Hodgkin Disease, Leukemia, Myeloid, Acute, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprolideDrug
Also called Lupron Depot-3(R), Leuprolide acetate
Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
hematopoietic cell transplantBiological
Also called HCT
Conventional bone marrow transplant regimen.
reduced intensity allogeneic HCTBiological
Also called RIC
A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
| Study group | Role | What they receive |
|---|---|---|
| Interventional - Received Leuprolide | Experimental | Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Receives: Drug: Leuprolide; Biological: hematopoietic cell transplant |
| Observational Arm | Active comparator | Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. Receives: Biological: reduced intensity allogeneic HCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Number of Patients With Ovarian Failure
Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH >40 IU/L) after transplant.
Measured: Through Day 180 Post Transplant
Secondary outcomes (14)
Comparison of Number of Patients Who Stopped Menstrual Bleeding
Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant
Measured: From Baseline Through Day 365
Comparison of Follicle Stimulating Hormone (FSH) Levels
Comparison of treatment arms; interventional versus observational average FSH levels.
Measured: Baseline
Comparison of Follicle Stimulating Hormone (FSH) Levels
Comparison of treatment arms; interventional versus observational average FSH levels.
Measured: Day 100
Comparison of Follicle Stimulating Hormone (FSH) Levels
Comparison of treatment arms; interventional versus observational average FSH levels.
Measured: Day 180
Comparison of Follicle Stimulating Hormone (FSH) Levels
Comparison of treatment arms; interventional versus observational average FSH levels.
Measured: 1 year
Comparison of Follicle Stimulating Hormone (FSH) Levels
Comparison of treatment arms; interventional versus observational average FSH levels.
Measured: 2 years
Comparison of Number of Patients Who Resumed Menstrual Cycles
Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant
Measured: Day 365 Post Transplant
Comparison of Lutineizing Hormone (LH) Levels
Comparison of treatment arms; interventional versus observational average LH levels during study.
Measured: Baseline
Comparison of Luteinizing Hormone (LH) Levels
Comparison of treatment arms; interventional versus observational average LH levels during study.
Measured: Day 100
Comparison of Luteinizing Hormone (LH) Levels
Comparison of treatment arms; interventional versus observational average LH levels during study.
Measured: Day 180
Comparison of Luteinizing Hormone (LH) Levels
Comparison of treatment arms; interventional versus observational average LH levels during study.
Measured: 1 year
Comparison of Leuprolide Hormone (LH) Levels
Comparison of treatment arms; interventional versus observational average LH levels during study.
Measured: 2 years
Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
Measured: Day Prior to Transplant
Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
Measured: Day 180 after Transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2015
- Study completionApr 2015
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 MyelomaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Medical Foundation
- Responsible party
- Sponsor
- Investigators
- Angela Smith, M.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343368
- Sponsor's protocol ID
- 2010LS053
- Other IDs
- 012M93555
- Status last verified
- Dec 2017
- First submitted
- 15 Mar 2011
- Last updated
- 5 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)
- ClinicalTrials.gov ID
- NCT01343368
- Acronym / sponsor ID
- 2010LS053
- Conditions
- Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Disease, Acute Myeloid Leukemia, Myeloproliferative Disorders
- Keywords
- Post-menarchal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- Minnesota Medical Foundation
- Study start
- Jul 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Posted 17 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.
Detailed description
This study is to use gonadotropin releasing hormone (GnRH) agonist leuprolide prior myeloablative hematopoietic cell transplantation to prevent ovarian dysfunction in post-menarchal women.
The primary objective is to determine the effect of GnRH agonists on the incidence of ovarian failure.
The secondary objectives are
- to determine how effective GnRH agonists are at suppressing menses during
- to determine the incidence and timing of resumption of menstrual cycles after HCT
- to determine the incidence and timing of resumption of normal FSH and LH levels after HCT
- to determine the incidence of normal AMH levels after HCT
- to determine the effect of GnRH agonists on immune reconstitution after HCT
- to assess the safety and tolerability of GnRH agonists in the context of HCT
A total of 47 patients will be accrued in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional - Received Leuprolide | Experimental | Drug: Leuprolide, Biological: hematopoietic cell transplantLong-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. |
| Observational Arm | Active comparator | Biological: reduced intensity allogeneic HCTWomen undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Interventional Arm:
- Observational Arm:
Key exclusion criteria (4 listed)
- All Arms:
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 |
|---|---|---|
| LeuprolideAlso: Lupron Depot-3(R), Leuprolide acetateLong-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days | Drug | Interventional - Received Leuprolide |
| hematopoietic cell transplantAlso: HCTConventional bone marrow transplant regimen. | Biological | Interventional - Received Leuprolide |
| reduced intensity allogeneic HCTAlso: RICA reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease. | Biological | Observational Arm |
Primary outcome
Comparison of Number of Patients With Ovarian Failure
Time frame: Through Day 180 Post Transplant
Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH >40 IU/L) after transplant.
14 secondary outcomes
Comparison of Number of Patients Who Stopped Menstrual Bleeding
Time frame: From Baseline Through Day 365
Comparison of Follicle Stimulating Hormone (FSH) Levels
Time frame: Baseline
Comparison of Follicle Stimulating Hormone (FSH) Levels
Time frame: Day 100
Comparison of Follicle Stimulating Hormone (FSH) Levels
Time frame: Day 180
Comparison of Follicle Stimulating Hormone (FSH) Levels
Time frame: 1 year
Comparison of Follicle Stimulating Hormone (FSH) Levels
Time frame: 2 years
Comparison of Number of Patients Who Resumed Menstrual Cycles
Time frame: Day 365 Post Transplant
Comparison of Lutineizing Hormone (LH) Levels
Time frame: Baseline
Comparison of Luteinizing Hormone (LH) Levels
Time frame: Day 100
Comparison of Luteinizing Hormone (LH) Levels
Time frame: Day 180
Comparison of Luteinizing Hormone (LH) Levels
Time frame: 1 year
Comparison of Leuprolide Hormone (LH) Levels
Time frame: 2 years
Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Time frame: Day Prior to Transplant
Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Time frame: Day 180 after Transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- 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.
Angela Smith, M.D. principal investigator
Masonic Cancer Center, University of Minnesota
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 Leuprolide, hematopoietic cell transplant and reduced intensity allogeneic HCT in people with Multiple Myeloma and Non-Hodgkin Lymphoma, run by Masonic Cancer Center, University of Minnesota 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 10 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: stopped early, as of the sponsor's last update on 5 Dec 2017. 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 Jul 2017). 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?
Comparison of Number of Patients With Ovarian Failure (time frame: Through Day 180 Post 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 5 Dec 2017.