Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 69 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female patients 18 to 69 years old. 2. Patient with primary plasma cell leukemia disease as defined by the International Myeloma Working Group -IMWG (Annexe I) 3. 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 4. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2. 5. Eligible for high dose Melphalan therapy with ASCT. 6. Total bilirubin <= 2 X the upper limit of the normal range (ULN). 7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 ULN. 8. Calculated creatinine clearance >= 20 mL/min. 9. 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.) 10. 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.) 11. 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.
12. Must be able to adhere to the study visit schedule and other protocol requirements. 13. Affiliated with an appropriate social security system.

Exclusion Criteria:

1. Male or female patients <18 or > 69 years old. 2. Prior history of malignancies, unless free of the disease for ≥ 5 years. 3. Prior history of symptomatic myeloma; did not received any previous chemotherapy for myeloma except corticotherapy (dexamethasone 40 mg/d for 4 days max). 4. Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation. 5. Pregnant or breast feeding females. 6. Known positive for HIV. 7. 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) 8. 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. 9. Patient with severe renal failure that require dialysis and clearance creatinine < 20 ml/min. 10. 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.) 11. Evidence of central nervous system (CNS) involvement. 12. Unable to take corticosteroid therapy, daratumumab, bortezomib and or lenalidomide at study entry. 13. Ongoing active infection, especially ongoing pneumonitis. 14. 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. 15. Patients with a left ventricular ejection fraction under to 40 % (LVEF <40%). 16. Use of any other experimental drug or therapy within 15 days of screening. 17. Any >grade 2 toxicity unresolved. 18. Inability or unwillingness to comply with birth control requirements. 19. Unable to take antithrombotic medicines at study entry. 20. Major surgery within 14 days before enrolment. 21. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. 22. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. 23. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of daratumumab and lenalidomide including difficulty swallowing

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bruno Royer, MD
Principal Investigator Affiliation Assistance Publique - Hôpitaux de Paris
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Not yet recruiting

The disease, disorder, syndrome, illness, or injury that is being studied.

Plasma Cell Leukemia
Arms & Interventions


Experimental: Experimental Arm

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


Drug: - Daratumumab

Daratumumab added to induction, first consolidation and second consolidation

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Bruno Royer, MD

01 42 49 96 92

For additional contact information, you can also visit the trial on