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A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497961
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : August 10, 2022
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to compare maintenance therapy approaches in people with newly diagnosed multiple myeloma (MM) that has responded well to a first round of treatment. The researchers will compare giving the usual maintenance therapy (lenalidomide) with giving daratumumab as maintenance therapy, and they will look at which drug gives participants a better health-related quality of life during treatment. The researchers will measure participants' quality of life using various questionnaires. This study will help researchers find out whether this different approach of giving daratumumab as maintenance therapy is better, the same as, or worse than the usual approach.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide Drug: Daratumumab Behavioral: Questionnaires Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a two-arm randomized pilot study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Daratumumab Versus Lenalidomide Maintenance Therapy for Multiple Myeloma: A Randomized Pilot Study Comparing Patient-Reported Health Related Quality of Life Measures With a Plant Based Nutrition Intervention Sub Study (NUTRIVENTION-4)
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Lenalidomide maintenance

Those randomized to lenalidomide maintenance will receive a maintenance dose of 10mg oral lenalidomide on days 1-21 of each 28-day cycle. HRQoL with EORTC QLQ-C30, EORTC QLQ-MY20 and PRO-CTCAE questionnaires will be collected: prior to therapy initiation (baseline); day 1 of cycle 2 and every cycle day 1 thereafter; at therapy discontinuation, and at 1-month post therapy follow-up.

ARM A1: The first 15 patients on each arm interested in this sub study will be enrolled during C10D1 visit to initiate whole food plant based diet (WFPBD) meals and nutrition counseling on C13D1 for 12 weeks followed by additional 12 weeks of counseling alone from C16D1. They will continue on their lenalidomide maintenance schedule per study calendar.

ARM A2: The patients who do not go on the nutrition sub study will continue on their lenalidomide maintenance schedule per study calendar.

Drug: Lenalidomide
dose of 10mg oral lenalidomide on days 1-21 of each 28-day cycle.

Behavioral: Questionnaires
EORTC QLQ-C30, EORTC QLQ-MY20, PRO-CTCAE)

Experimental: Daratumumab maintenance

Those randomized to receive daratumumab maintenance will receive 1800 milligrams (mg) subcutaneous (SC) injection of daratumumab as follows: days 1, 8, 15, and 22 of cycles 1 and 2; days 1 and 15 of cycles 3-6; day 1 of cycles 7-36. HRQoL with EORTC QLQ-C30, EORTC QLQ-MY20 and PRO-CTCAE questionnaires will be collected: prior to therapy initiation (baseline); day 1 of cycle 2 and every cycle day 1 thereafter; at therapy discontinuation, and at 1-month post therapy follow-up.

ARM B1: The first 15 patients on each arm interested in this sub study will be enrolled during C10D1 visit to initiate whole food plant based diet (WFPBD) meals and nutrition counseling on C13D1 for 12 weeks followed by additional 12 weeks of counseling alone from C16D1. They will continue on their daratumumab maintenance schedule per study calendar.

ARM B2: The patients who do not go on the nutrition sub study will continue on their daratumumab maintenance schedule per study calendar.

Drug: Daratumumab
1800 milligrams (mg) subcutaneous (SC) injection of daratumumab as follows: days 1, 8, 15, and 22 of cycles 1 and 2; days 1 and 15 of cycles 3-6; day 1 of cycles 7-36

Behavioral: Questionnaires
EORTC QLQ-C30, EORTC QLQ-MY20, PRO-CTCAE)




Primary Outcome Measures :
  1. Difference in the global health status [ Time Frame: 3 years ]
    The primary comparison across the two treatment arms will use a mixed effects linear regression model.


Secondary Outcome Measures :
  1. difference in overall survival and progression-free survival [ Time Frame: 3 years ]
    Evaluation using traditional IMWG uniform response criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with plasma cell myeloma treated with combination therapy with or without ASCT, who at the time of study enrollment have documented evidence of very good partial response (VGPR) or better according to International Myeloma Workshop Consensus Panel.
  • Enrollment within 6 months from completion of initial combination therapy (with or without ASCT).
  • Age ≥18 years.
  • ECOG performance status ≤ 2 (see Appendix A).
  • Subjects who have had ASCT may enroll following minimum 100-day washout per standard guidelines
  • Patient must have adequate hematologic, renal, and hepatic function as defined by:

    • Absolute neutrophil count ≥ 1.0K /μL (growth factor support is permissible)
    • Platelets ≥ 50K/μL (transfusions are permissible)
    • Hemoglobin ≥ 8 g/dL (transfusions are permissible)
    • Creatinine clearance (CrCl) of greater than or equal to 40 mL/min. using the CKD-EPI formula (see Appendix C). If the CrCl based on the CKD-EPI formula is <40 mL/min, the patient will have a 24 hr urine collection to measure CrCl. The measured CrCl must also be ≥ 40 ml/min.
    • Total bilirubin ≤ 2 mg/dL (exception: documented Gilbert's syndrome), AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
  • Patients must be able to take daily prophylactic anticoagulation medication, such as: aspirin (81 or 325 mg) warfarin, low molecular weight heparin, or other medications as clinically indicated.
  • Patients must be able to take prophylactic antiviral medication such as acyclovir or valacyclovir
  • Patient must understand and voluntarily sign an informed consent form, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.

Additional inclusion criteria for patients randomized to arm A:

  • Study participants must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of the REMS® program.
  • Women of childbearing potential should be advised to avoid becoming pregnant and must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. They must be agreeable to use acceptable methods of birth control throughout the study and for at least 4 weeks after stopping lenalidomide. Recommendation is for 2 effective contraceptive methods during the study and for at least 4 weeks after the last dose. Adequate forms of contraception are double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation.
  • A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).
  • Females of childbearing potential who have not previously taken Lenalidomide must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS®).
  • Females of childbearing potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
  • Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy. See Appendix B: Lenalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

Additional inclusion criteria for patients randomized to arm B:

  • Females of reproductive potential must agree to use an effective method of birth control during treatment and for at least 3 months after cessation of daratumumab.
  • Males who are sexually active with a female of reproductive potential must agree to use an effective method of birth control during treatment and for at least 3 months after cessation of daratumumab.
  • Subjects agree to not donate eggs/sperm for 3 months following cessation of daratumumab.

Additional inclusion criteria for patients interested in the nutrition intervention:

  • Interest in a plant based diet and plant based recipes

Exclusion Criteria:

  • Patients with progressive or refractory plasma cell myeloma, as defined by International Myeloma Workshop Consensus Panel criteria.
  • History of disease refractory to lenalidomide or daratumumab, as defined by the IMWG as failure to achieve minimal response or development of progressive disease while on therapy.
  • Multiple myeloma patients who have received prior anti myeloma therapy for smoldering myeloma
  • Patients who are receiving any other investigational agents with the intent to treat myeloma. Permitted concurrent therapies include:
  • Bisphosphonates/RANK ligand inhibitors (denosumab)
  • Plasma cell leukemia
  • Pregnant or breastfeeding females. Because there is a potential risk for adverse events to nursing infants secondary to treatment of the mother with lenalidomide, lactating females must agree not to breastfeed while taking lenalidomide.
  • Risk for adverse events to nursing infants secondary to treatment of the mother with daratumumab is unknown, as such lactating females must agree not to breastfeed while on daratumumab.
  • Patient has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal).
  • Patient has known moderate or severe persistent asthma, within the last 2 years, or currently has uncontrolled asthma of any classification (refer to Appendix D). (Subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.)
  • Uncontrolled hypertension or diabetes
  • 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.
  • Hepatitis C PCR positive excluded (If antibody positive and PCR negative they will be eligible but must have PCR testing every 3-6 months for 3 years; If treated must have a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
  • Diagnosed or treated for another malignancy within 3 years prior to study enrollment, with the exception of complete resection of non-melanoma skin cancer, or an in-situ malignancy.
  • Previous diagnosis of another malignancy with any evidence of residual or active disease.
  • Uncontrolled or detectable HIV viral load excluded. (Patients seropositive for the human immunodeficiency virus (HIV), and/or those who are taking antiretroviral treatment for HIV/AIDS with undetectable viral load will be eligible. Patients must have PCR testing every 3-6 months for 3 years and be compliant with antiretroviral treatment.)
  • Prior organ transplant requiring immunosuppressive therapy
  • Prior allogeneic stem cell transplant
  • Patients requiring continuous, systemic immunosuppressive therapy
  • Patients with myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled cardiac arrhythmias, or electrocardiographic evidence of acute ischemia
  • Patients with conditions that would prevent absorption of the study drug
  • Uncontrolled intercurrent illness including but not limited to uncontrolled infection or psychiatric illness/social situations that would compromise compliance with study requirements
  • Unresolved prior treatment related AE ≥ grade 2 except for alopecia and neuropathy
  • Neuropathy ≥ Grade 3 at baseline
  • Contraindication to required concomitant anticoagulation or antiviral prophylaxis
  • Major surgery within 1 month prior to enrollment
  • Patients who were previously exposed and who developed severe adverse events, hypersensitivity or desquamating rash to either thalidomide or lenalidomide
  • Patients who speak a language that does not have an EORTC QLQ-C30, MY20 or PRO-CTCAE version translated into their language (Available languages include Chinese, Czech, Danish, Dutch, French, German, Greek, Hugarian, Italian, Japanese, Korean, Malay, Polish, Protugese, Romanian, Russian, Spanish, Turkish, Ukranian).

Additional exclusion criteria for patients interested in the nutrition intervention:

  • Legume allergy
  • Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497961


Contacts
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Contact: Urvi Shah, MBBS 212-639-7016 shahu@mskcc.org
Contact: Sham Mailankody, MBBS 212-639-2131

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Urvi Shah, MBBS    212-639-7016      
Memoral Sloan Kettering Monmouth (Limited Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Urvi Shah, MBBS    212-639-7016      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Urvi Shah, MBBS    212-639-7016      
United States, New York
Memorial Sloan Kettering Commack (Limited protocol activities) Recruiting
Commack, New York, United States, 11725
Contact: Urvi Shah, MBBS    212-639-7016      
Memorial Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Urvi Shah, MBBS    212-639-7016      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Urvi Shah, MBBS    212-639-7016      
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Urvi Shah, MBBS    212-639-7016      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Janssen Scientific Affairs, LLC
Investigators
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Principal Investigator: Urvi Shah, MBBS Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04497961    
Other Study ID Numbers: 20-198
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Daratumumab
Lenalidomide
Patient-Reported Health Related
Quality of Life Measures
20-198
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Daratumumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents