Relapsed Hematologic MalignancyPhase 2NCT03413800
Len/Dex/DLI in Relapsed Multiple Myeloma After Allogeneic Stem Cell Transplant
A Phase 2 study testing Lenalidomide-Dexamethasone-DLI in people with Relapsed Hematologic Malignancy and Multiple Myeloma, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
Multiple Myeloma (MM) is a morbid disease which can only be cured with an allogeneic hematopoietic stem cell transplant (HSCT). Approximately 50% of allotransplanted patients will relapse, with a median survival of 5 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsed Hematologic Malignancy, Multiple Myeloma
- What is being tested?
- Lenalidomide-Dexamethasone-DLI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 12 Feb 2018to 27 Mar 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Myeloma patients in first relapse after a sibling or unrelated allogeneic stem cell transplantation
- Patients with measurable disease at time of relapse based on the IMWG criteria
- All study participants must comply with the Revlimid Pregnancy Prevention Plan.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Pregnancy Prevention Plan.
Who cannot join
- Relapse occurred within 180 days post allograft
- Refractory to Len at any given time before allogeneic transplantation
- Presence of ≥ grade II or uncontrolled acute GVHD
- Presence of severe or uncontrolled chronic GVHD
- Karnofsky score < 70%
- Bilirubin > 50 μmol/L unless felt to be related to Gilbert's disease or hemolysis; AST and ALT > 5 x upper limit of normal (ULN); alkaline phosphatase > 5 x ULN
Show all 22Show fewer
- Known hypersensitivity to Len or Dex
- Active infection with any of the following viruses: HIV, HTLV-1 or 2, hepatitis B (defined as HBsAg positivity) or hepatitis C (defined as anti-HCV positivity or HCV-RNA positivity)
- Presence of another malignancy with an expected survival estimated < 75% at 5 years (complete resection of basal cell carcinoma or squamous cell carcinoma, complete resection of a ductal carcinoma in situ, presence of lobular carcinoma in situ, complete resection of carcinoma in situ of the cervix, or an in situ or low-risk prostate cancer after curative therapy are not exclusion criteria)
- Positive beta-human chorionic gonadotropin pregnancy test, to be performed in all women of childbearing potential at screening and baseline. Female study participants who are surgically sterile (hysterectomy) or who have been postmenopausal for at least 12 consecutive months are automatically eligible for this criterion
- Females of child-bearing potential not agreeing to remain abstinent or to use 2 simultaneous effective methods of contraception from at least 4 weeks before, to at least 4 weeks following discontinuation of Len. Males not agreeing to use a condom during any sexual contact with females of child-bearing potential from at least 4 weeks before, to at least 4 weeks following discontinuation of Len
- Women who are lactating
- Female of child-bearing potential who are planning to become pregnant while enrolled in this study up to 4 weeks after the last Len dose
- Participation in a trial with an investigational agent within 30 days prior to entry in the study
- Inability to provide written informed consent prior to initiation of any study-related procedures, or inability, in the opinion of investigators, to comply with all requirements of the study
- Estimated probability to survive less than 6 months after initiation of Len and Dex
- Current history of drug and/or alcohol abuse
- Any abnormal condition or laboratory result that is considered by investigators capable of altering patient's condition, compliance or study outcome
- Any patient who, in the opinion of investigators, should not participate in this study
- Having received allogeneic stem cell transplantation in relapse after autologous transplant.
- Having received Len therapy after allogeneic transplant, before relapse
- Poor organ function defined as either: diffusing capacity of the lung for carbon monoxide corrected for hemoglobin using Dinakara method (DLCOc) < 50%; forced expiratory volume in 1 second < 50%; left ventricular ejection fraction (LVEF) < 40% evaluated by echocardiogram or multi-gated acquisition scan (MUGA); uncontrolled arrhythmia; symptomatic cardiac disease; creatinine clearance < 30 mL/minute; liver cirrhosis
Trial locations and contacts
1 site in 1 country.
Canada1 site
CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve Rosemond
Montreal, Quebec, H1T2M4
About this study
Official title: A Phase II, Open-label Study of Lenalidomide and Dexamethasone Followed by Donor Lymphocyte Infusions in Relapsed Multiple Myeloma Following Allogeneic Stem Cell Transplant
Multiple Myeloma (MM) is a morbid disease which can only be cured with an allogeneic hematopoietic stem cell transplant (HSCT). Approximately 50% of allotransplanted patients will relapse, with a median survival of 5 years. Better approaches to improve disease control at relapse, while decreasing toxicity, are urgently needed.
Relapse after allogeneic transplant is a failure of the graft versus MM effect (GvMM). DLIs can be used to control disease following relapse, but the optimal dose, schedule of administration and drug association remain elusive, while the immunosuppression found in MM patients can compromise their effect. One reason for immunotherapy failure relates to the immunological environment: as much as myeloma cells depend on their microenvironment to survive and proliferate, the immunotherapeutic effect of allogeneic HSCT depends on both systemic and local immunological status to be efficacious. Immunomodulatory drugs such as Lenalidomide (Len) have been tried in various settings after allogeneic transplantation with the aim to reverse immunosuppression and stimulate the GvMM, but if and how Len influences a GvMM and thereby promotes an immunotherapeutic success remained uncharacterized. Therefore, a deeper understanding of the immunological environment in MM patients is needed in order to establish and / or restore a potent GvMM effect.
Read more
This study proposes the powerful combination of the two following goals, one clinical and one biological :
- Clinical: The investigators propose a two-step treatment using first Len in association with Dexamethasone (Dex), followed by Donor Leukocytes Infusions (DLIs) to offer an optimal disease control strategy in relapsed patients. The cytoreductive and immunomodulatory effects of Len is expected to induce a permissive immunological environment for the immunotherapeutic activity of DLIs to develop, while the association with Dex will lessen the risk of graft-versus-host disease (GVHD). This treatment combination has the potential to further improve depth of myeloma response, delay myeloma progression and improve patient survival.
- Biological: In an attempt to gain knowledge on how the GvMM behaves in MM patients post-relapse after having received a combined treatment of Len/Dex/DLIs, the investigators propose to characterize the immune environment of their bone marrow (BM) using both minimal residual disease (MRD) assessement by flow cytometry and an unbiased analysis of the transcriptome at various time points.
Read the detailed description
Myeloma patients in first relapse after sibling or unrelated donor allogeneic transplant willing to participate in this study will be screened for eligibility.
- After baseline evaluation including BM aspirate for plasma cell count, minimal residual disease using 8-color multiparameter flow cytometry, transcriptome sequencing and a positron emission tomography (PET scan), patients will receive Len- Dex daily x 21 days with Dex 40 mg once weekly for a total of 6 cycles of 28 days each
- Patients will then be evaluated clinically for acute and chronic GVHD before each cycle and a PET scan will be performed at the end of Len/Dex treatment
- Sibling and unrelated donor transplant recipients will receive 3 DLIs
- Disease and immune evaluation using serum and urine electrophoresis/immunofixation in addition to measurement of serum-free light chains, BM aspirate for plasma cell count and minimal residual disease using 8-color multiparameter flow cytometry, transcriptome sequencing and a PET scan will be performed
- A BM aspirate will be performed before each DLI for plasma cell count, MRD evaluation by flow cytometry and transcriptome sequencing
- Patients will be followed with a BM aspirate every 3 months x 1 year, then yearly and at progression for plasma cell count and evaluation
- Transcriptome sequencing will be done on BM aspirates at time of relapse, after Len/Dex cycles, 6m, 12m, 18m and 24m after the last-DLI.
- A PET scan will be performed after the last DLI and at progression.
- Conditions
- Relapsed Hematologic Malignancy, Multiple Myeloma
- Being tested
- Lenalidomide-Dexamethasone-DLI
- Keywords
- hematopoietic stem cell transplant, lenalidomide, DLI
- Medical subject headings
- Hematologic Neoplasms, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide-Dexamethasone-DLIDrug
Lenalidomide (Len) and Dexamethasone (Dex) for 6 months followed by three donor lymphocyte infusions (DLIs)
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide-Dexamethasone-DLI | Experimental | 1. Patients will receive Len (10 mg in the presence of ≤ grade I acute GVHD or absence of chronic GVHD; 5 mg in presence of controlled mild or moderate chronic GVHD) daily x 21 days with Dex 40 mg once weekly for a total of 6 cycles of 28 days each
1. For grade ≥III non hematologic or grade IV hematologic toxicity, Len can be reduced to 5 mg
2. In absence of these toxicities, acute GVHD (using Glucksberg modified criteria) or severe chronic GVHD (using NIH criteria), Len dose can be increased by 5 mg per cycle to a maximum of 25 mg
2. If eligibility is confirmed, sibling and unrelated donor transplant recipients will both receive 3 donor lymphocyte infusions (DLIs) at the following doses: 5 x 106 CD3+/kg; 1 x 107 CD3+/kg; 5 x 107 CD3+/kg
3. Patient will be followed for 5 years post relapse. Receives: Drug: Lenalidomide-Dexamethasone-DLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Len-Dex-DLI in patients with relapsed myeloma measured by progression-free survival
To determine the as efficacy of Len and Dex followed by DLIs, measured by progression-free survival at 2 years after the last DLI
Measured: 2 years
Secondary outcomes (12)
Incidence of grade ≥III non hematologic toxicity and incidence of grade ≥IV hematologic toxicity
Patients will be evaluated according to protocol and adverse events will be monitored continuously, documented and collected in database
Measured: 5 years
Incidence of acute GVHD
GVHD will be evaluated according to protocol, documented and collected in database. Analysis will be done by cumulative incidence.
Measured: 1 years
Incidence of chronic GVHD
GVHD will be evaluated according to protocol, documented and collected in database. Analysis will be done by cumulative incidence.
Measured: 2 years
Maximum grades of acute and chronic GVHD
GVHD will be evaluated according to protocol, documented and collected in database
Measured: 2 years
Response to treatment
International Myeloma Working Group (IMWG) response after Len/Dex and after DLIs, best response achieved
Measured: 3 years
Non-relapse mortality after DLIs
Analysis by cumulative incidence
Measured: 3 years
Overall survival at 2 years
Kaplan Meier analysis
Measured: 2 years
Incidence of progression at 2 years
Kaplan Meier analysis
Measured: 2 years
Disease status assessment by flow cytometry
BM evaluation of minimal residual disease (MRD) by multiparametric flow cytometry (MFC) analysis
Measured: 5 years
Disease status assessment by PET scan
Evaluation of extramedullary disease by positron emission tomography (PET) scan
Measured: 5 years
Evaluation of quality of life (QoL) during treatment
QoL questionnaire will be given to patients according to protocol
Measured: 5 years
Evaluation of the BM microenvironment by transcriptome analysis before and after treatments
Both mononucleated celles and extracellular compartment will be analyzed by RNAseq
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start12 Feb 2018
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Hematologic MalignancyStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene, C3i Center Inc.
- Responsible party
- Principal investigator, Jean Roy, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Jean Roy, MD, Principal investigator, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413800
- Sponsor's protocol ID
- HMR003
- Status last verified
- May 2026
- First submitted
- 15 Jan 2018
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label Study of Lenalidomide and Dexamethasone Followed by Donor Lymphocyte Infusions in Relapsed Multiple Myeloma Following Allogeneic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT03413800
- Acronym / sponsor ID
- HMR003
- Conditions
- Relapsed Hematologic Malignancy, Multiple Myeloma
- Keywords
- hematopoietic stem cell transplant, lenalidomide, DLI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Celgene, C3i Center Inc.
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 29 Jan 2018 (actual)
- 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.
Multiple Myeloma (MM) is a morbid disease which can only be cured with an allogeneic hematopoietic stem cell transplant (HSCT). Approximately 50% of allotransplanted patients will relapse, with a median survival of 5 years. Better approaches to improve disease control at relapse, while decreasing toxicity, are urgently needed.
Relapse after allogeneic transplant is a failure of the graft versus MM effect (GvMM). DLIs can be used to control disease following relapse, but the optimal dose, schedule of administration and drug association remain elusive, while the immunosuppression found in MM patients can compromise their effect. One reason for immunotherapy failure relates to the immunological environment: as much as myeloma cells depend on their microenvironment to survive and proliferate, the immunotherapeutic effect of allogeneic HSCT depends on both systemic and local immunological status to be efficacious. Immunomodulatory drugs such as Lenalidomide (Len) have been tried in various settings after allogeneic transplantation with the aim to reverse immunosuppression and stimulate the GvMM, but if and how Len influences a GvMM and thereby promotes an immunotherapeutic success remained uncharacterized. Therefore, a deeper understanding of the immunological environment in MM patients is needed in order to establish and / or restore a potent GvMM effect.
This study proposes the powerful combination of the two following goals, one clinical and one biological :
- Clinical: The investigators propose a two-step treatment using first Len in association with Dexamethasone (Dex), followed by Donor Leukocytes Infusions (DLIs) to offer an optimal disease control strategy in relapsed patients. The cytoreductive and immunomodulatory effects of Len is expected to induce a permissive immunological environment for the immunotherapeutic activity of DLIs to develop, while the association with Dex will lessen the risk of graft-versus-host disease (GVHD). This treatment combination has the potential to further improve depth of myeloma response, delay myeloma progression and improve patient survival.
- Biological: In an attempt to gain knowledge on how the GvMM behaves in MM patients post-relapse after having received a combined treatment of Len/Dex/DLIs, the investigators propose to characterize the immune environment of their bone marrow (BM) using both minimal residual disease (MRD) assessement by flow cytometry and an unbiased analysis of the transcriptome at various time points.
Detailed description
Myeloma patients in first relapse after sibling or unrelated donor allogeneic transplant willing to participate in this study will be screened for eligibility.
- After baseline evaluation including BM aspirate for plasma cell count, minimal residual disease using 8-color multiparameter flow cytometry, transcriptome sequencing and a positron emission tomography (PET scan), patients will receive Len- Dex daily x 21 days with Dex 40 mg once weekly for a total of 6 cycles of 28 days each
- Patients will then be evaluated clinically for acute and chronic GVHD before each cycle and a PET scan will be performed at the end of Len/Dex treatment
- Sibling and unrelated donor transplant recipients will receive 3 DLIs
- Disease and immune evaluation using serum and urine electrophoresis/immunofixation in addition to measurement of serum-free light chains, BM aspirate for plasma cell count and minimal residual disease using 8-color multiparameter flow cytometry, transcriptome sequencing and a PET scan will be performed
- A BM aspirate will be performed before each DLI for plasma cell count, MRD evaluation by flow cytometry and transcriptome sequencing
- Patients will be followed with a BM aspirate every 3 months x 1 year, then yearly and at progression for plasma cell count and evaluation
- Transcriptome sequencing will be done on BM aspirates at time of relapse, after Len/Dex cycles, 6m, 12m, 18m and 24m after the last-DLI.
- A PET scan will be performed after the last DLI and at progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide-Dexamethasone-DLI | Experimental | Drug: Lenalidomide-Dexamethasone-DLI1. Patients will receive Len (10 mg in the presence of ≤ grade I acute GVHD or absence of chronic GVHD; 5 mg in presence of controlled mild or moderate chronic GVHD) daily x 21 days with Dex 40 mg once weekly for a total of 6 cycles of 28 days each 1. For grade ≥III non hematologic or grade IV hematologic toxicity, Len can be reduced to 5 mg 2. In absence of these toxicities, acute GVHD (using Glucksberg modified criteria) or severe chronic GVHD (using NIH criteria), Len dose can be increased by 5 mg per cycle to a maximum of 25 mg 2. If eligibility is confirmed, sibling and unrelated donor transplant recipients will both receive 3 donor lymphocyte infusions (DLIs) at the following doses: 5 x 106 CD3+/kg; 1 x 107 CD3+/kg; 5 x 107 CD3+/kg 3. Patient will be followed for 5 years post relapse. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years
- Myeloma patients in first relapse after a sibling or unrelated allogeneic stem cell transplantation
- Patients with measurable disease at time of relapse based on the IMWG criteria
- All study participants must comply with the Revlimid Pregnancy Prevention Plan.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Pregnancy Prevention Plan.
Key exclusion criteria (22 listed)
- Relapse occurred within 180 days post allograft
- Refractory to Len at any given time before allogeneic transplantation
- Presence of ≥ grade II or uncontrolled acute GVHD
- Presence of severe or uncontrolled chronic GVHD
- Karnofsky score < 70%
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 |
|---|---|---|
| Lenalidomide-Dexamethasone-DLILenalidomide (Len) and Dexamethasone (Dex) for 6 months followed by three donor lymphocyte infusions (DLIs) | Drug | Lenalidomide-Dexamethasone-DLI |
Primary outcome
Efficacy of Len-Dex-DLI in patients with relapsed myeloma measured by progression-free survival
Time frame: 2 years
To determine the as efficacy of Len and Dex followed by DLIs, measured by progression-free survival at 2 years after the last DLI
12 secondary outcomes
Incidence of grade ≥III non hematologic toxicity and incidence of grade ≥IV hematologic toxicity
Time frame: 5 years
Incidence of acute GVHD
Time frame: 1 years
Incidence of chronic GVHD
Time frame: 2 years
Maximum grades of acute and chronic GVHD
Time frame: 2 years
Response to treatment
Time frame: 3 years
Non-relapse mortality after DLIs
Time frame: 3 years
Overall survival at 2 years
Time frame: 2 years
Incidence of progression at 2 years
Time frame: 2 years
Disease status assessment by flow cytometry
Time frame: 5 years
Disease status assessment by PET scan
Time frame: 5 years
Evaluation of quality of life (QoL) during treatment
Time frame: 5 years
Evaluation of the BM microenvironment by transcriptome analysis before and after treatments
Time frame: 3 years
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 8 May 2026.
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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.
Jean Roy, MD principal investigator
Ciusss de L'Est de l'Île de Montréal
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 Lenalidomide-Dexamethasone-DLI in people with Relapsed Hematologic Malignancy and Multiple Myeloma, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 5 inclusion and 22 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 8 May 2026. 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 Canada. 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.
What does the primary outcome measure?
Efficacy of Len-Dex-DLI in patients with relapsed myeloma measured by progression-free survival (time frame: 2 years). 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 8 May 2026.