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PCL-2 - PRIMARY PLASMA CELL LEUKEMIA: A PROSPECTIVE PHASE II STUDY INCORPORATING DARATUMUMAB TO CHEMOTHERAPY AND STEM CELL TRANSPLANTATION (PCL-2 STUDY)
EU CTIS ID: 2024-515037-15-00
What this study is testing
To determine the best overall Response rate at completion of induction phase (very good partial response or better)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients 18 to 69 years old.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN.
- Calculated creatinine clearance ≥ 20 mL/min (MDRD formulashould be used for calculating creatinine clearance values)
- Female patients who: -Have been postmenopausal for at least 2 years before thescreening visit, OR -Are surgically sterile, OR If they are of childbearingpotential, agree to practice 2 effective methods ofcontraception, at the same time, from the time of signing theinformed consent form through 90 days after the last doseof study drug, OR -Agree to practice true abstinence when this is in line withthe preferred and usual lifestyle of the subject. (Periodicabstinence [e.g., calendar, ovulation, symptothermal andpost-ovulation methods] and withdrawal are not acceptablemethods of contraception.)
- Affiliated with an appropriate social security system.
- 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.)
You likely can't join if
- Male or female patients <18 or >69 years old
- 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 corticotherapy, 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
See the full eligibility criteria
Who can join
- Male or female patients 18 to 69 years old.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN.
- Calculated creatinine clearance ≥ 20 mL/min (MDRD formulashould be used for calculating creatinine clearance values)
- Female patients who: -Have been postmenopausal for at least 2 years before thescreening visit, OR -Are surgically sterile, OR If they are of childbearingpotential, agree to practice 2 effective methods ofcontraception, at the same time, from the time of signing theinformed consent form through 90 days after the last doseof study drug, OR -Agree to practice true abstinence when this is in line withthe preferred and usual lifestyle of the subject. (Periodicabstinence [e.g., calendar, ovulation, symptothermal andpost-ovulation methods] and withdrawal are not acceptablemethods of contraception.)
- Affiliated with an appropriate social security system.
- 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
- Patient with primary plasma cell leukemia disease as definedby the recent International Myeloma Working Group (IMWG2021): ≥ 5% circulating plasma cells in peripheral blood smears
- Voluntary written consent must be given before performance ofany study related procedure not part of standard medical care,with the understanding that consent may be withdrawn by thepatient at any time without prejudice to future medical care
- Eastern Cooperative Oncology Group (ECOG) performancestatus 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).
What rules you out
- Male or female patients <18 or >69 years old
- 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 corticotherapy, 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
- 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
- History of malignancy within 3 years before the date of inclusion (exceptions are squamous and basal cell carcinomas of the skin, carcinoma of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the coordinating Investigatior, is considered cured with minimal risk of recurrence within 3 years)
- Major surgery within 14 days before enrolment.
- Prior history of symptomatic myeloma with 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
- 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 clairance creatinine < 20 ml/min
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.