Plasma Cell LeukemiaPhase 2PCL-2NCT05054478
Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation
A Phase 2 study testing Daratumumab in people with Plasma Cell Leukemia, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Single-Arm phase 2 trial evaluating efficacy of incorporating Daratumumab to treatment of newly diagnosed primary plasma cell leukemia. Treatment will be based on Dara-VRd induction followed by first ASCT, Dara-VRd for first consolidation, second ASCT, Dara-VRd for 1 year as second consolidation and Lenalidomide for 1… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Plasma Cell Leukemia
- What is being tested?
- Daratumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18 to 69 years old.
- Patient with primary plasma cell leukemia disease as defined by the International Myeloma Working Group -IMWG (Annexe I)
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
- Eligible for high dose Melphalan therapy with ASCT
- Total bilirubin <= 2 X the upper limit of the normal range (ULN).
Show all 20Show fewer
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 ULN.
- Calculated creatinine clearance >= 20 mL/min
- Female patients who:
- Have been postmenopausal for at least 2 years before the screening visit, OR
- are surgically sterile, OR If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
- Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Patients agree
- not to share study medication with any other person and to return all unused study drugs to the investigator.
- to abstain from donating blood while taking the study drug therapy and for one week following discontinuation of the study drug therapy.
- Must be able to adhere to the study visit schedule and other protocol requirements
- Affiliated with an appropriate social security system
Who cannot join
- Male or female patients <18 or > 69 years old
- Prior history of malignancies, unless free of the disease for ≥ 5 years.
- Prior history of symptomatic myeloma; did not received any previous chemotherapy for myeloma except corticotherapy (dexamethasone 40 mg/d for 4 days max).
- Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.
- Pregnant or breast feeding females
- Known positive for HIV
Show all 23Show fewer
- Known seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as a viremia at least 12 weeks after completion of antiviral therapy)
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti- HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
- Patient with severe renal failure that require dialysis and clearance creatinine < 20 ml/min
- Prior local irradiation within two weeks before first dose. However, an exception (that is patients allowed to remain in the treatment phase of the study) is made for radiation therapy to a pathological fracture site to enhance bone healing or to treat post-fracture pain that is refractory to narcotic analgesics because pathologic bone fractures do not by themselves fulfil a criterion for disease progression.)
- Evidence of central nervous system (CNS) involvement
- Unable to take corticosteroid therapy, daratumumab, bortezomib and or lenalidomide at study entry.
- Ongoing active infection, especially ongoing pneumonitis
- Ongoing Cardiac dysfunction: specify e.g. uncontrolled hypertension, MI within 6 months, unstable Angina pectoris, Cardiac arrhythmia Grade 2 or higher, NYHA class III/IV
- Patients with a left ventricular ejection fraction under to 40 % (LVEF <40%).
- Use of any other experimental drug or therapy within 15 days of screening.
- Any >grade 2 toxicity unresolved
- Inability or unwillingness to comply with birth control requirements
- Unable to take antithrombotic medicines at study entry
- Major surgery within 14 days before enrolment
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of daratumumab and lenalidomide including difficulty swallowing
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation : PCL-2 Study
Single-Arm phase 2 trial evaluating efficacy of incorporating Daratumumab to treatment of newly diagnosed primary plasma cell leukemia. Treatment will be based on Dara-VRd induction followed by first ASCT, Dara-VRd for first consolidation, second ASCT, Dara-VRd for 1 year as second consolidation and Lenalidomide for 1 year.
- Conditions
- Plasma Cell Leukemia
- Being tested
- Daratumumab
- Medical subject headings
- Leukemia, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Daratumumab added to induction, first consolidation and second consolidation
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | 4 days of dexamethasone. According to local practice, one dose of doxorubicine (30 mg/m2 IV) or cyclophosphamide (750 mg/m2 IV) may also be added
Induction Treatment (4 months): Subject will receive 4 x 28 days cycles of Dara-VRD induction:
Daratumumab sc 1800 mg on D1 D8 D15 D22 for cycle1 \& 2 and D1 D15 for cycle 3 \& 4 Bortezomib sc 1.3 mg/m2 on D1 D4 D8 D11 for each cycle Lenalidomide po 25 mg on D1 to D21 for each cycle Dexamethasone po 20 mg on D1 D2 D8 D9 D15 D16 D22 D23 for each cycle
High dose melphalan 200mg/m2 as conditioning therapy and first ASCT
First consolidation : 2 cycles of Dara-VRd
* Daratumumab 1800 mg s.c D1 D15
* Bortezomib 1.3 mg/m2 s.c D1 D8 D15 D22
* Lenalidomide 25 mg p.o from D1 to D21
* Dexa 20 mg p.o D1 D8 D15 D22
High dose melphalan 200mg/m2 as conditioning therapy and second ASCT Second consolidation : 6 cycles of Dara-VRd (every 2 months for 2 years) Then maintenance: Lenalidomide every 28 days (25 mg from D1 to D21) for 1 year Receives: Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
VGPR or better at the completion of induction phase
The VGPR or better rate (as determined by the reviewer) is defined as the proportion of patients with confirmed IMWG criteria for VGPR, CR or stringent CRrelative to the total number of patients in the ITT population
Measured: completion of induction phase [4 Months]
Secondary outcomes (20)
Progression Free Survival
Measured: 3 years
Response rates (sCR, CR, VGPR, PR, SD):
Measured: after induction [4 months]
Response rates (sCR, CR, VGPR, PR, SD):
Measured: after ASCT n°2 [10 months]
Response rates (sCR, CR, VGPR, PR, SD):
Measured: after second consolidation phase [22 months]
Response rates (sCR, CR, VGPR, PR, SD):
Measured: end of treatment [34 months]
Overall response rate (ORR)
Measured: after induction [4 months]
Overall response rate (ORR)
Measured: after ASCT n°2 [10 months]
Overall response rate (ORR)
Measured: after second consolidation phase [22 months]
Overall response rate (ORR)
Measured: end of treatment [34 months]
Overall survival (OS)
Measured: 3 years
Time to progression (TTP)
Measured: 3 years
Duration of response (DOR)
Measured: 3 years
Safety
Adverse Events
Measured: Whole trial duration [48 months]
MRD negative rate assessed by NGS
Measured: End of induction [4 months]
MRD negative rate assessed by NGS
Measured: after ASCT n°2 [10 months]
MRD negative rate assessed by NGS
Measured: after second consolidation phase [22 months]
MRD negative rate assessed by NGS
Measured: end of treatment [34 months]
Quality of life
defined using EORTC QLQ-C30 domain scores
Measured: End of induction [4 months]
Quality of life
defined using EORTC QLQ-C30 domain scores
Measured: after ASCT n°2 [10 months]
Quality of life
defined using EORTC QLQ-C30 domain scores
Measured: after second consolidation phase [22 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study startOct 2021 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell LeukemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm phase 2 trial
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Royer, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054478
- Sponsor's protocol ID
- APHP190205
- Other IDs
- 2019-004170-26, 2019
- Acronym
- PCL-2
- Status last verified
- May 2021
- First submitted
- 31 Jul 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation : PCL-2 Study
- ClinicalTrials.gov ID
- NCT05054478
- Acronym / sponsor ID
- PCL-2 / APHP190205
- Conditions
- Plasma Cell Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Sep 2021 (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.
Single-Arm phase 2 trial evaluating efficacy of incorporating Daratumumab to treatment of newly diagnosed primary plasma cell leukemia. Treatment will be based on Dara-VRd induction followed by first ASCT, Dara-VRd for first consolidation, second ASCT, Dara-VRd for 1 year as second consolidation and Lenalidomide for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm phase 2 trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Daratumumab4 days of dexamethasone. According to local practice, one dose of doxorubicine (30 mg/m2 IV) or cyclophosphamide (750 mg/m2 IV) may also be added Induction Treatment (4 months): Subject will receive 4 x 28 days cycles of Dara-VRD induction: Daratumumab sc 1800 mg on D1 D8 D15 D22 for cycle1 \& 2 and D1 D15 for cycle 3 \& 4 Bortezomib sc 1.3 mg/m2 on D1 D4 D8 D11 for each cycle Lenalidomide po 25 mg on D1 to D21 for each cycle Dexamethasone po 20 mg on D1 D2 D8 D9 D15 D16 D22 D23 for each cycle High dose melphalan 200mg/m2 as conditioning therapy and first ASCT First consolidation : 2 cycles of Dara-VRd * Daratumumab 1800 mg s.c D1 D15 * Bortezomib 1.3 mg/m2 s.c D1 D8 D15 D22 * Lenalidomide 25 mg p.o from D1 to D21 * Dexa 20 mg p.o D1 D8 D15 D22 High dose melphalan 200mg/m2 as conditioning therapy and second ASCT Second consolidation : 6 cycles of Dara-VRd (every 2 months for 2 years) Then maintenance: Lenalidomide every 28 days (25 mg from D1 to D21) for 1 year |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female patients 18 to 69 years old.
- Patient with primary plasma cell leukemia disease as defined by the International Myeloma Working Group -IMWG (Annexe I)
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
- Eligible for high dose Melphalan therapy with ASCT
Key exclusion criteria (23 listed)
- Male or female patients <18 or > 69 years old
- Prior history of malignancies, unless free of the disease for ≥ 5 years.
- Prior history of symptomatic myeloma; did not received any previous chemotherapy for myeloma except corticotherapy (dexamethasone 40 mg/d for 4 days max).
- Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation.
- Pregnant or breast feeding females
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 |
|---|---|---|
| DaratumumabDaratumumab added to induction, first consolidation and second consolidation | Drug | Experimental Arm |
Primary outcome
VGPR or better at the completion of induction phase
Time frame: completion of induction phase [4 Months]
The VGPR or better rate (as determined by the reviewer) is defined as the proportion of patients with confirmed IMWG criteria for VGPR, CR or stringent CRrelative to the total number of patients in the ITT population
20 secondary outcomes
Progression Free Survival
Time frame: 3 years
Response rates (sCR, CR, VGPR, PR, SD):
Time frame: after induction [4 months]
Response rates (sCR, CR, VGPR, PR, SD):
Time frame: after ASCT n°2 [10 months]
Response rates (sCR, CR, VGPR, PR, SD):
Time frame: after second consolidation phase [22 months]
Response rates (sCR, CR, VGPR, PR, SD):
Time frame: end of treatment [34 months]
Overall response rate (ORR)
Time frame: after induction [4 months]
Overall response rate (ORR)
Time frame: after ASCT n°2 [10 months]
Overall response rate (ORR)
Time frame: after second consolidation phase [22 months]
Overall response rate (ORR)
Time frame: end of treatment [34 months]
Overall survival (OS)
Time frame: 3 years
Time to progression (TTP)
Time frame: 3 years
Duration of response (DOR)
Time frame: 3 years
Safety
Time frame: Whole trial duration [48 months]
MRD negative rate assessed by NGS
Time frame: End of induction [4 months]
MRD negative rate assessed by NGS
Time frame: after ASCT n°2 [10 months]
MRD negative rate assessed by NGS
Time frame: after second consolidation phase [22 months]
MRD negative rate assessed by NGS
Time frame: end of treatment [34 months]
Quality of life
Time frame: End of induction [4 months]
Quality of life
Time frame: after ASCT n°2 [10 months]
Quality of life
Time frame: after second consolidation phase [22 months]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
Related trials for Plasma Cell Leukemia
RecruitingObservational study
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Recruiting
Mosaic Trial for Stem Cell Transplant Recipients
Hematologic Malignancy, Stem Cell Transplant
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia
RecruitingObservational study
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
Graft-versus-leukemia, Graft vs Host Disease
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.
Bruno Royer, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daratumumab in people with Plasma Cell Leukemia, run by Assistance Publique - Hôpitaux de Paris.
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 20 inclusion and 23 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: opening soon, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Royer, MD (01 42 49 96 92 ext. 0033, bruno.royer@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VGPR or better at the completion of induction phase (time frame: completion of induction phase [4 Months]). 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 23 Sep 2021.